Device Approvals & Patents
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Spine/Neurology
FDA Clears NuVasive's Thoracolumbar Portfolio for Sagittal Deformity Treatment
The clearance expands the portfolio's indications from one- to two-level spine surgery, to now multiple levels.PR Newswire 11.09.20
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Extremities
FH Ortho Unveils e-Ortho Planification Software
The software provides shoulder replacement surgeons with a web-based platform to assist in preoperative surgical technique planning.Globe Newswire 10.05.20
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Spine/Neurology
Orthofix FIREBIRD SI Fusion System Receives Additional FDA Clearance for Nanotechnology
The system enables surgeons to pack the device with autograft and/or allografts to help promote bone fusion.Business Wire 10.01.20
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Extremities
Carbon22 Receives FDA 510(k) Clearance for FusionFrame Ring Lock System
The Consortium-designed circular external fixator can treat complex foot/ankle deformities and provide a static frame for various indications.EINPresswire 09.30.20
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Spine/Neurology
FDA Clears Life Spine's SI Joint Revision Offering
Additional claims for the SImpact Sacroiliac Joint Fixation System were also cleared.Business Wire 09.23.20
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Spine/Neurology
CTL Amedica Receives TFDA License for Three Silicon Nitride Spine Products
The Valeo product line is projected to commercialize later this year in Taiwan.CTL Amedica Corporation 09.11.20
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Spine/Neurology
FDA Grants CTL Amedica 510k Clearance for MONDRIAN LIF Cage System
The product is indicated for intervertebral body fusion procedures in patients with degenerative disc disease at one or two adjoining levels from L2-S1.CTL Amedica 09.02.20
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Spine/Neurology
Safe Orthopaedics Receives FDA 510(k) Approval for Second Generation of SteriSpine PS
Company has gradually been rolling out the technology this year in Japan, certain areas in Europe, and the Asia-Pacific region.Globe Newswire 08.13.20
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Spine/Neurology
HAPPE Spine Awarded Additional Technology Patent For Porous, Bioactive PEEK
The technology marries the desired characteristics of porosity and bioactivity into a strong, osteointegrative, and radiolucent material.PR Newswire 07.10.20
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Extremities
FDA Clears Nextremity Solutions' Cannulated Hammertoe System
Product is indicated for small bone reconstruction limited to interphalangeal repair and fusion of the lesser toes.Nextremity Solutions Inc. 07.07.20
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Large Joint
FDA Clears iTotal Identity PS Knee System
iTotal Identity PS joins iTotal Identity CR as the latest personalized knee technology from Conformis.Globe Newswire 06.22.20
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Spine/Neurology
U.S., Europe Approve Two KONG VBR Spinal Systems From icotec
Products feature endplates in various profiles, sizes, angles, and alignments.icotec ag 06.19.20
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Biologics
SIRAKOSS Receives U.S. FDA 510(k) Clearance for Osteo3 ZP Putty
Combines best-in-class bone repair with intraoperative ease-of-use for spine and trauma bone grafting applications.SIRAKOSS Ltd. 06.17.20
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Large Joint
Naviswiss Wins FDA Clearance for its Miniature Hip Navigation
The system can be used with a variety of surgical approaches and most implants on the market.Naviswiss AG 06.15.20
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Spine/Neurology
FDA Clears Nexxt Spine's ALIF and Lateral Systems
Additional FDA clearances roll in for growing spinal manufacturer to be available in the third quarter.Nexxt Spine LLC 06.01.20
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Spine/Neurology
FDA Approves Manufacturing Transfer of Centinel Spine's prodisc Technology
The transfer and site change involved FDA inspection audits and approval of a PMA supplement.PR Newswire 05.29.20
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Extremities
FDA Clears Nextremity Solutions' Metatarsophalangeal Joint Arthrodesis System
The clearance marks the continued expansion of the company's portfolio to address additional complications in the foot.PRWeb 05.26.20
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Spine/Neurology
FDA Clears Zebra Medical's Vertebral Compression Fractures AI Solution
Product is the company's fifth to be okayed by the FDA.Business Wire 05.19.20
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Spine/Neurology
Safe Orthopaedics Registers Several Trademarks in Japan
Company also is working to acquire LCI Médical.Business Wire 05.15.20
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Large Joint
Corin's OPSInsight Receives 510(k) Clearance for Use in THA
New cloud-based software brings Corin’s flagship Optimized Positioning System onto a dynamic online platform.EIN Presswire 05.14.20
