fda clearance
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Regulatory
VySpine Announces FDA Clearances for VySpan, VyLam and VySpine Innovations
Trio of Clearances Expands VySpine’s Growing Product Portfolio Tallahassee, FL – October 17, 2023—VySpine, a spine innovation leader using…
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Regulatory
FDA clears Intelivation Technologies new Hammerdesis™ Interphalangeal Fusion System
SAINT SIMONS ISLAND, Ga., Oct. 10, 2023 /PRNewswire/ — Intelivation Technologies, an innovative medical device company with a cutting-edge orthopedic portfolio announced…
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Spine
SurGenTec® Unveils TiLink™—Revolutionary Posterior Sacroiliac Fusion System Featuring Novel Compression Capability
BOCA RATON, Fla., October 3, 2023–(BUSINESS WIRE)–SurGenTec, a privately held medical device company focusing on spine and orthopedic technologies, proudly…
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Regulatory
Tyber Medical Gains FDA And MDR Clearance For Its Implantable K-Wires And Steinmann Pins In Stainless Steel And Titanium Alloy
BETHLEHEM, Pa., Sept. 21, 2023 /PRNewswire/ — Tyber Medical, a leader in the medical device industry, is pleased to announce that it…
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Spine
Karolinska Development’s portfolio company OssDsign has received FDA clearance for a new major indication
STOCKHOLM, SWEDEN, September 19, 2023 – Karolinska Development AB (Nasdaq Stockholm: KDEV) announces that its portfolio company OssDsign has received…
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Spine
Wenzel Spine Receives FDA Clearance Expanding Clinical Indications for primaLOK SP
AUSTIN, Texas, August 22, 2023–(BUSINESS WIRE)–Wenzel Spine, Inc., a medical technology company specializing in the development of a minimally invasive…
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Spine
Curiteva® Announces FDA Clearance of Pedicle & SI Navigation Instrument System
Huntsville, AL based technology company Curiteva® announces FDA 510(k) clearance to market a Navigation Instrument System to complement their Prodigy®…
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Regulatory
Axial3D Receives FDA Clearance for Axial3D INSIGHT™ Medical Image Segmentation Platform
Cloud-based solution advances personalized healthcare through scalable, personalized 3D solutions driven by artificial intelligence. BELFAST, Northern Ireland, July 31, 2023–(BUSINESS WIRE)–Axial3D,…
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Regulatory
Inovedis Receives FDA Clearance of the SINEFIX™ Implant System for Rotator Cuff Repair
Company to Launch SINEFIX in Selected Clinical Sites in 2023 ALBSTADT, Germany, July 6, 2023 /PRNewswire/ — Inovedis GmbH, a medical technology start-up dedicated…
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Spine
SurGenTec’s TiLink-L Receives FDA Clearance, Leading the Way as the First Offering in its Advanced Sacroiliac Joint Fusion Portfolio
BOCA RATON, Fla., June 9, 2023 –(BUSINESS WIRE)– A leader in innovative medical devices, is proud to announce clearance from…
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Regulatory
First Light Field-Enabled Spine Surgery Navigation Platform, Proprio Paradigm™, Receives FDA Clearance
Proprio’s Paradigm platform enables spine surgeons to operate more efficiently by providing fast registration and reducing the need for intraoperative…
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Spine
VySpine Announces FDA Clearance for UniVy OsteoVy-Ti Cervical IBF with NanoVy-HA
Tallahassee, FL — April 25, 2023 /OrthoSpineNews/ — VySpine, a spine innovation leader using differentiated materials and designs, announced today…
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Biologics
Abyrx Receives Additional FDA Clearances for MONTAGE® Settable, Resorbable Bone Putty as Bone Void Filler and Cranial Bone Cement
STAMFORD, Conn., April 5, 2023 /PRNewswire/ — Abyrx, Inc. (http://abyrx.com), a leading biomaterial sciences company with a focus on therapeutic technologies for…
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Spine
Spinal Resources Inc. Unveils Groundbreaking Spine Platform for Improved Patient Care
FDA-cleared Bezier Rod platform provides an unparalleled solution to address critical spinal conditions and improve patient outcomes. FORT LAUDERDALE, FL.,…
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Sports Medicine
FDA Provides Clearance of First-Ever Device for ACL Reconstruction in Children
Designed to address an “epidemic” of knee injuries in younger skeletally immature athletes, the device was developed and adapted for…
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