FDA 510(k) Clearance
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Extremities
Anika Receives FDA 510(k) Clearance for the X-Twist™ Knotless Fixation System, Expanding its Sports Medicine Soft Tissue Portfolio
X-Twist provides a simple, versatile knotless suture anchor system ideal for key repairs in the shoulder, foot and ankle, and…
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Spine
Accelus Receives U.S. FDA 510(k) Clearance for its Toro-L Interbody Fusion System
PALM BEACH GARDENS, Fla., May 19, 2022 (GLOBE NEWSWIRE) — Accelus, a privately held medical technology company focused on accelerating…
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Regulatory
FDA grants 510k clearance of the CTL Amedica Navigation Instrument System
DALLAS, MAY 18, 2022 – OrthoSpineNews – CTL Amedica Corporation has received official 510k clearance from the U.S. Food and…
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Regulatory
CoNextions TR® Tendon Repair System Receives FDA Clearance
SALT LAKE CITY, April 25, 2022 /PRNewswire/ — CoNextions® Inc. (www.conextionsmed.com), an innovator in tendon repair, is pleased to announce that CoNextions TR®…
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Regulatory
Nextremity Solutions, Inc. Announces 510(k) Clearance of the StealthFix™ Intraosseous Fixation System
Improvements made to upcoming StealthFix System WARSAW, IND. (PRWEB) APRIL 21, 2022 Nextremity Solutions, Inc., a Strategic Commercialization Organization (SCO) with…
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Spine
SpineGuard obtains FDA clearance for commercial release of its “Threaded PediGuard” in anterior approach spine surgery
PARIS & BOULDER, CO, April 04, 2022 / OrthoSpineNews / – SpineGuard (FR0011464452 – ALSGD) (Paris:ALSGD), an innovative company that deploys…
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Regulatory
Orthofix Announces FDA Clearance and First Patient Cases With the TrueLok EVO Ring Fixation System
Designed for complex limb reconstruction and deformity correction procedures, the system features radiolucent rings and struts for clearer visualization under…
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Spine
CoreLink Announces First Of Its Kind Fusation™ 3D Printed Cervical Anchor
The CoreLink® Fusation™ anchors are the first additively manufactured porous anchors designed for robust fixation and bony attachment in challenging…
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Spine
VySpine Announces FDA Clearance for LumiVy Lumbar IBF System
Tallahassee, FL – March 8, 2022 / OrthoSpineNews / – VySpine, a spine innovation leader using differentiated materials and designs,…
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Recon
Exactech Smart Shoulder Technology Now Features Humeral Planning and Joint Motion
The Equinoxe Planning App (v.2.0) allows for humeral head offsets and replicator plate positioning. (Photo: Business Wire) GAINESVILLE, Fla.–(BUSINESS WIRE)–Exactech,…
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Spine
Bone Solutions Inc. Receives FDA Clearance for Mg OSTEOREVIVE Spine Magnesium-Based Bone Void Filler
Colleyville, TX (February 2, 2022) / OrthoSpineNews / — Bone Solutions Inc. (BSI), a orthobiologics technology company located in Colleyville,…
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Spine
VySpine Announces FDA Clearance for ClariVy Cervical IBF System
Tallahassee, FL – February 1, 2021 / OrthoSpineNews / – VySpine, VySpine, a spine innovation leader using differentiated materials and…
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Regulatory
VUZE Medical Announces U.S. FDA 510(k) Clearance for Its VUZE System
Real-time Image Processing Enables Software-Only Guidance and Verification in Minimally Invasive Spine Surgery January 18, 2022 RA’ANANA, Israel–(BUSINESS WIRE)–VUZE Medical,…
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Financial
Surgalign Receives FDA Clearance for HOLO Portal™ System, the World’s First AI-driven AR Guidance System for Spine Surgery and Reports Preliminary Fourth Quarter and Full Year 2021 Results
Clearance is for use in the lumbar portion of the $5 billion instrumented fusion market* DEERFIELD, Ill., Jan. 18, 2022…
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Spine
VySpine Announces FDA Clearance of the VySpan PCT System
Tallahassee, FL – January 6, 2021 / OrthoSpine News / – VySpine, a spine innovation leader using differentiated materials and…
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