spinal simplicity fda approval

Pico single-use negative pressure wound therapy system from Smith+Nephew 3. Provider Diagnosis Codes - ICD- 10-CM Diagnosis Coding All providers (hospitals, physicians, ASCs, etc.) Spinal Simplicity's Minuteman device is available for sale in the United States, according to a Kansas City Business Journal. About Spinal Simplicity Spinal Simplicity is dedicated to the creation of innovative simple solutions to treat complex spinal conditions. 238 / Wednesday, December 15, 2021 / Proposed Rules Electronic Submissions DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 888 [Docket No. . A new-generation, non-articulating disc implant, the M6 (Spinal Kinetics, Sunnyvale, CA), incorporates PCU in its core to add a shock absorbance capacity and a limited ROM. Jonathan helped attain 2 FDA clearances and a CE mark approval for a spinal . sys: MEDTRONIC NEUROMODULATION: P840001 S002: 03/26/1985: itrel(r) totally implantable spinal . On December 17, 2021, Spinal Simplicity announced the much-anticipated FDA clearance of a new Indication for Use (IFU) for its Minuteman family of implants, Lumbar Spinal Stenosis. Background X-spine's stated philosophy in designing and manufacturing surgical implants and instrumentation for use in spinal surgery is a combination of . The Golden Isles Pedicle Screw System is designed to provide immobilisation and stabilisation of spinal segments in skeletally mature patients in treating the lumbar and sacral spine. Devices Orthopaedic Neurosurgery FDA. Image: Mazor Website. The Golden Isles Pedicle Screw System™ is designed to provide immobilization and stabilization of spinal segments in skeletally mature patients in treating the lumbar and sacral spine. 86, No. 3. This causes discomfort in the legs when standing or walking because of pressure on the spinal nerves.There are several treatment options for LSS including physiotherapy, lumbar surgical decompression procedures such as laminectomy, Foraminotomy, Discectomy and more recently . US FDA approves Medtronic's Intellis spinal cord stimulation device. MinuteMan G3 ® is developed by Spinal Simplicity, LLC, which was founded by Dr. Harold Hess, a neurosurgeon, in 2008 and Todd Moseley, an entrepreneur. Spinal Stenosis Devices Market Size Expected to Soar at a Steady CAGR of 2.71% by 2026, Estimates DelveInsight The Spinal Stenosis Devices Market is set to rise due to the rise in the number of . Stable-L standalone lumbar interbody system from Nexus Spine. Enhanced complex spine portfolio. Dec 17, 2021 Spinal Simplicity Minuteman Lumbar Spinal Stenosis Indication for Use Overland Park, KS - December 17, 2021 - Spinal Simplicity, a medical device company, today announced the much-anticipated FDA clearance of a new Indication for Use (IFU) for its Minuteman family of implants, Lumbar Spinal Stenosis. SAINT SIMONS ISLAND, Ga., Sept. 1, 2021 /PRNewswire/ -- Intelivation Technologies, a medical device . Augmedics gained FDA approval for its wireless headset on Dec. 23. Spinal Tech 24 orthopedic devices approved by FDA in December Laura Dyrda - Updated Wednesday, January 12th, 2022 Print | Email Listen Text The FDA granted 24 orthopedic devices clearance in December. "For companies to try […] overland park, KS 66210. Posterior Fusion Plate, HA Posterior Fusion Plate from Spinal Simplicity. The FDA granted several spine-related device approvals last month. Taperloc Complete Hip Stems from Biomet Orthopedics 5. "Hydroxyapatite has been used in orthopaedic procedures for the last 30 years because of its successful track record," says Todd Moseley, chief executive officer and co-founder, Spinal Simplicity. NuVasive thoracolumbar interbody systems 2. A 2020 report by Public Citizen accused the FDA of "dangerously lax" oversight of stimulators, which were linked to 156,000 injuries and 931 deaths. (percutaneous spinal fusion) Spinal Simplicity Yes Unlike premarket notification, PMA approval is to be based on a determination by FDA that the PMA contains sufficient valid . Posterior Fusion Plate, HA Posterior Fusion Plate from Spinal Simplicity 4. The minimally invasive device provides fixation and stabilization of the lumbar spine while bone graft material propagates and ultimately provides as full stabilization between vertebrae . The device is designed to alleviate pain from pinched nerves in the spinal column. A number of interspinous process fixation devices have been approved by the U.S. Food and Drug Administration (FDA) 510(k) clearance process and are used an adjunct to interbody fusion. 1. Submitted By: Southern Spine LLC Spinal stenosis is a condition in which the gaps inside the spine narrow tend to put pressure on the nerves that run through it, being most common in the lower back and . . Unlike a spinal fusion procedure, this implant allows for more movement in. FLASHBACK: Spinal Simplicity will sell implantable device in Europe The device runs about $7,000 to $10,000 and has been approved in Israel, Italy, Germany and Switzerland and is in active clinical. 11th August 2014. Cerapedics Receives FDA Approval for i-FACTOR (TM) Peptide Enhanced Bone Graft in Cervical Spine Surgery. A PMA is an application submitted to FDA to request approval to market. Spinal device company X-spine Systems Inc. has announced two new U.S. FDA clearances for its products: The Fortex ™ CoCr Rod System and the Certex™ Cervico-thoracic Fixation System. received the FDA approval for Thoracolumbosacral Pedicle . HSMN NewsFeed - 3 Nov 2015. 6.91 Mar 09, 2017: Stryker's Spine To Present on AERO -C Cervical Cage System at AAOS 2017 165. the company expects to gain approval to sell its device in Italy — a move that could assist the FDA application, said Mike . Tailored-C Cervical Interbody Fusion System from BeSpoke Technologies. Overland Park-based Spinal Simplicity LLC will begin selling its first product, an implantable spinal device, this summer in Europe, another big step to entering the U.S. market. Aurora Spine in July won CE Mark approval in the European Union for its 1st spinal fusion product, and the company hopes to have FDA approval in hand before the end of the year, according to its . Our Products Spinal Simplicity aims to provide surgeons with innovative, minimally invasive, simple solutions to treat complex spinal disorders. Background The Simplify Cervical Artificial Disc is designed to stabilize the spine after the removal of a damaged or diseased disc. NuVasive thoracolumbar interbody systems 2. Spinal Simplicity says that the PercLIF surgical approach and instrumentation provide a way of quickly and accurately placing the Minuteman between the spinous processes through a 1" incision. In August 2021, Aurora Spine Corporation received FDA . Intelivation Technologies received FDA approval for the Golden Isles Pedicle Screw System™. K151741. 18th September 2017. Spinal stenosis is a condition in which the gaps inside the spine narrow tend to put pressure on the nerves that run through it, being most common in the lower back and neck. 1. Spinal Simplicity was granted FDA 510 (k) clearance for the HA Minuteman ® G3 in August of 2015 and for the HA Minuteman ® G3R in January of 2017. In January 2015, FDA 510(k) clearance was approved for the Minuteman G3 device. Scolioscreen-smartphone device reliably measures angle of trunk inclination. 1. Spinal Simplicity's Minuteman device will be backbone of growth. itrel(r) totally implantable spinal cord stim. FDA is summarizing its proposed findings regarding the. The FDA granted 24 spine devices clearance in December. Spinal Simplicity Lands Investor In Nueterra Capital, Advances Opportunity For FDA-Cleared Minuteman Fusion Device Manufacturer of surgical solutions expands innovative spinal surgery in U.S. market 1. Fixone All Suture Anchor form AJU PHarm 2. Zimmer Segmental System from Zimmer 3. Reliance cervical IBF system from Reliance Medical Systems. The Minuteman ® MIS Fusion Plate is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). FDA or Other Governmental Regulatory Approval U.S. Food and Drug Administration (FDA) The following interspinous fixation devices have been cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. Developed by Spinal Simplicity, the FDA approved spinal fusion device Minuteman G3R offers a revolutionary approach for medical professionals like Dr. Sneddon. A 2020 report by Public Citizen accused the FDA of "dangerously lax" oversight of stimulators, which were linked to 156,000 injuries and 931 deaths. 6.90 Mar 13, 2017: Spineology Announces Expanded FDA Clearance of Elite Expandable Interbody Fusion System 165. The . • Minuteman® Interspinous Interlaminar Fusion Device (percutaneous spinal fusion) (Spinal Simplicity) . Intelivation Technologies received FDA approval for the Golden Isles Pedicle Screw System™ Published: Sep 01, 2021 SAINT SIMONS ISLAND, Ga. , Sept. 1, 2021 /PRNewswire/ -- Intelivation Technologies, a medical device company with a cutting-edge spinal implant product portfolio announced today that they have achieved FDA 510(k) Clearance of the . Minuteman Interspinous Interlaminar Fusion Device (Spinal Simplicity), Percutaneous spinal fusion, SP-Fix Spinous Process Fixation System (Globus Medical), BridgePoint (Alphatec Spine), Axle Interspinous fusion system (X-Spine), Aileron posterior fusion system (Life Spine), BacFus Spinous Process . Spinal Simplicity has launched a new generation of Minuteman G3 fusion device, featuring a US Food and Drug Administration (FDA)-cleared coating of hydroxyapatite. 510 (k) Number. sys: MEDTRONIC NEUROMODULATION: P840001 S438: 07/29/2019: restore, itrel, synergy and intellis spinal cord s. • ™Aerial Interspinous Fixation (Globus Medical Inc.) • Affix 4. Spinal USA (Pearl, MS) has announced that its Slimplicity Solo anterior cervical plate system has been cleared via FDA's 510 (k) pathway, making it the third product that the company has . Ironically, the report noted that spinal . (Chou, 2021; Levin, 2021). Tailored-C Cervical Interbody Fusion System from BeSpoke . The Minuteman ® MIS Fusion Plate may be implanted via a minimally invasive lateral (L1-S1) approach. 2. FDA approves Mazor robot for brain surgery "As neurosurgeons focus on both the spine and brain, brain surgeries represent a large market opportunity that is closely aligned with our current focus." Mazor Robotics Ltd. has announced that it has obtained US Food and Drug Administration (FDA) approval for its Renaissance surgical guidance… Here are five key notes: 1. HSMN NewsFeed - 10 Nov 2015. SPINAL SIMPLICITY LLC K083020 2019-1846 K051665 2019-1852 K911599 2019-1853 K894410 2019-1854 . Precision Spine, Inc. has announced that its wholly owned subsidiary, Spinal USA, Inc., has received 510 (k) clearance from the FDA for the Slimplicity® Solo Anterior Cervical Plate System, adding another important cervical product to the broad and expanding Spinal USA product portfolio. Golden Isles Pedicle Screw System™ is designed to provide immobilization & stabilization of spinal segments in skeletally mature pts RX the lumbar/sacral spine. This technology has been validated at 5 million cycles of compression and torque testing, and is currently utilized in the Minuteman® by Spinal Simplicity™, which is being implanted in patients in Europe, Israel, and the U.S. Spinal Simplicity™ was granted FDA 510(k) approval for the Minuteman® in January 2015. The Minuteman® is delivered sterile and individually packed.' Developed by Spinal Simplicity, the FDA approved spinal fusion device Minuteman G3R offers a revolutionary approach for spine surgeons and pain management specialists. The core threaded post allows for optimal placement and a wide range of sizes allows for enhanced anatomical fit. Intelivation Technologies has announced that the company has achieved US Food and Drug Administration (FDA) 510(k) clearance of its Golden Isles Pedicle Screw System. sys: MEDTRONIC NEUROMODULATION: P840001 S001: 02/07/1985: itrel(r) totally implantable spinal cord stim. The first device, Axis-ALIF was cleared by the FDA in May 2020, US surgeries started in November 2020. 3. We seek to enhance patient care through an array of minimally invasive products and are leaders in designing lateral MIS fusion devices. A number of interspinous process fixation devices have been approved by the Food and Drug Administration (FDA) and received 510(k) clearance for use as an adjunct to interbody fusion. In January 2015 the MinuteMan G3 device was granted FDA 510(k) clearance for use in the United States. Interspinous fixation devices are also being evaluated for stand-alone use in patients with spinal stenosis. NGM Wave PLIF cage from NGMedical 3. May 2011, Spinal Simplicity received CE approval to make the MinuteMan device available to patients in Europe. Toro-L interbody fusion system from Integrity Implants. 1. Centerpiece plate fixation system from Medtronic Sofamor Danek 6. Reports the latest medical device, clinical trials, product launches, funding, mergers/acquisitions and diagnostic news. It is intended for plate. HA Minuteman G3 MIS Fusion Plate. It is intended for use with bone graft material and is not intended for stand-alone use. The Superion InterSpinous Spacer was FDA approved in 2015 and is an H-shaped implant composed of titanium alloy. Fix-C PEEK anterior cervical interbody system from Jeil Medical 5. Lumbar spinal stenosis (LSS) is a narrowing of the spinal canal that compresses the neural elements in the lower . FDA approval also comes at a time when the agency is under growing scrutiny for its regulation of medical devices, particularly spinal cord stimulators. ShurFit lumbar interbody system from Precision Spine 4. Intelivation Technologies today announced that it has received FDA 510(k) clearance for its Golden Isles pedicle screw system. FDA-2021-N-0309] Effective Date of Requirement for Premarket Approval Applications for Spinal Spheres for Use in Intervertebral Fusion Procedures Food and Drug Administration, Department . The FDA granted clearance of 40 orthopedic and spine devices in December. The FDA granted clearance of 17 spine devices in December. Nevro Corp. has announced FDA approval for expanded labeling of its Senza spinal cord stimulation system for use in patients with non-surgical refractory back pain, according to a press release . These devices . Spinal Simplicity's vision is to be the global leader in innovative, simplified surgical solutions, Spinal Simplicity, a medical device company based in Overland Park, Kan., that develops innovative solutions to treat complex surgical problems, recently announced a new generation of their Minuteman G3 fusion device that features an FDA-cleared coating of hydroxyapatite (HA). It is intended for treatment of degenerative disc disease. The FDA determines The Spinal Simplicity Spinous Process Fusion (SPF) Plate is a minimally invasive, spinous process fusion plate designed for attachment to the posterior, non-cervical spine at the spinous processes through its bilateral locking Plates, and it is intended for use with bone Spinal Stenosis: Overview . The Spinal Simplicity Posterior Fusion Plate is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). Note, the fact a service, procedure, or device is FDA approved for a specific indication does not, in itself, make the procedure medically reasonable and necessary. US FDA clears Spinal Simplicity's Minuteman G3-R removable end fusion implant. 2. SPINAL SIMPLICITY LLC. This list may not be exhaustive. The use of one of Subject: Interspinous Process Fixation Devices for Spinal Fusion Original Effective Date: 3/11/2019 Policy Number: MCP-339 Revision Date(s): Medtronic has discontinued the distribution of the X-Stop system. Jonathan Hess is the Vice President of Business Development for Spinal Simplicity, an emerging medical device firm. Federal Register / Vol. Applicant. FDA approves startup's AR headset for surgical guidance. Stenosis Devices companies such as Spinal Simplicity LLC, Boston . Spinal muscular atrophy (SMA) is the leading genetic cause of infant mortality [].SMA is characterized by the degeneration of α-motor neurons in the spinal cord, leading to progressive muscle weakness followed by respiratory insufficiency [1, 2].SMA is caused by low levels of Survival Motor Neuron (SMN) protein due to homozygous deletion or mutation of the SMN1 gene [3, 4]. It is intended for plate. In January 2017 the updated version, HA MinuteMan G3 that incorporates hydroxyapatite to promote bone fusion Minuteman Interspinous Interlaminar Fusion Device (Spinal Simplicity) The Food and Drug Administration (FDA or Agency) is proposing to require the filing of a premarket approval application (PMA) for spinal spheres for use in intervertebral fusion procedures, which is an unclassified, preamendments device. The Saint Simons Island, Georgia-based company designed the Golden Isles system to provide immobilization and stabilization of spinal segments in skeletally mature patients to treat the lumbar and sacral spine. Elegant Simplicity Axis Technology provides greater intra-operative correction capabilities than expandable cages without the risks associated with small moving parts that can wear or fatigue. The device received FDA approval in January. AxioMed is progressing toward FDA approval for its viscoelastic for lumbar and cervical disc replacement, the devicemaker said April 19.. Four things to know: 1. Device Name. Spinal Simplicity, LLC, headquartered in Overland Park, KS, is dedicated to the creation of simple solutions for the treatment of complex spinal disorders. Lumbar spinal stenosis (LSS), is a common disorder of narrowing of the spinal canal in the lower part of the back. The minimally invasive device provides fixation and stabilization of the thoracic, lumbar, and sacral spine while bone graft material propagates and ultimately forms a full . itrel(r) totally implantable spinal cord stim. Based on approval is dominated by the devices that have received FDA and CE mark approval both, occupying a share of 46% followed by the medical devices that have received FDA approval only . 6.89 Mar 15, 2017: Gary Henley Joins Spinal Simplicity 165. 3. Interventional Spine Gains FDA Clearance of Advanced Design of Its Expandable Opticage (R) for Spinal Fusion. Device name Manufacturer FDA Approved? AxioMed's disc is different from the current ball and socket design and is composed of a proprietary silica-based viscoelastic material, according to a news release. Developed by Spinal Simplicity, the FDA approved spinal fusion device Minuteman G3R offers a revolutionary approach for spine surgeons and pain management specialists. A startup . The X-STOP® PEEK IPD® System, a modified version of the original X-STOP system, received FDA approval in 2006. FDA approval also comes at a time when the agency is under growing scrutiny for its regulation of medical devices, particularly spinal cord stimulators. 6.92 Mar 09, 2017: Stryker's Spine division to exhibit on Xia CT at AAOS . FDA approved package insert, product labeling for Ornidyl (eflornithine injection) for the . The Spinal Simplicity Posterior Fusion Plate is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). The Spinal Implants Market Size is Expected to Increase at a CAGR of 5.37% by 2026, Assesses DelveInsight As per DelveInsight analysis, the Spinal Implants market size is anticipated to increase . must report a diagnosis code(s) when US FDA clears Spinal Simplicity's Minuteman G3-R removable end fusion implant 14th February 2017 4150 Spinal Simplicity has received its third 510 (k) clearance from the US Food and Drug Administration (FDA) for the Minuteman G3-R spinal implant, part of the Minuteman family of supplemental fusion and fixation devices. X-spine Lands FDA Approval for Two New Spinal Systems Published: Nov 02, 2012 X-spine, a global leader in the design and manufacture of devices for the treatment of spinal disease, today announced two new USFDA clearances for spinal systems: The Fortex ™ CoCr Rod System and the Certex™ Cervico-thoracic Fixation System. Based on approval is dominated by the devices that have received FDA and CE mark approval both, occupying a share of 46% followed by the medical devices that have received FDA approval only . DEC 2 12012 K123093, page 1 of 2 Southern Spine LLCI Traditional 510(k) -Southern Spine -StabiLlink TM MIS Spinal Fixation System 510(k) SUMMARY This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements under 21 CFR 807.92. have received approval for marketing from the U.S. Food and Drug Administration (FDA) for single-level fixation with bone graft material for achieving supplemental fusion. . Introduction. The HA Minuteman® G3 is a minimally invasive, interspinous-interlaminar fusion device that is identical to the Minuteman® G3 with the addition of hydroxyapatite coating added and is intended for the temporary fixation of the thoracic, lumbar and sacral 17 new spine devices get FDA approval. 510(k) clearance from the U.S. Food and Drug Administration for K2M's NILE Alternative Fixation Spinal System for complex spinal deformity cases. 14th February 2017. . The headset uses augmented reality for surgical guidance. 2. Applicant Contact. Spinal Simplicity has been granted 50 patents, two FDA 510(k) clearances and two CE mark approvals in our relentless pursuit of meaningful advancement of spinal and orthopedic implant . (Spacers) have been approved by the U.S Food and Drug Administration (FDA) Interspinous Fixation Devices (not an all-inclusive list) . sys: MEDTRONIC NEUROMODULATION: P840001 : 11/30/1984: itrel(r) totally implantable spinal cord stim. 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