FDA 510(k) Clearance
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Regulatory
FX Receives 510k Clearance for FX V135® Shoulder Arthroplasty Platform
The FX V135® is an Anatomical or Reverse Construct with Options at 135° or 145° DALLAS, June 8, 2022 /PRNewswire/ — FX…
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Spine
Aurora Spine Corporation Receives FDA 510(k) Clearance for DEXA SOLO-L™ Anterior Lumbar Interbody Fusion Device as part of its DEXA Technology Platform
CARLSBAD, Calif, June 06, 2022 (GLOBE NEWSWIRE) — Aurora Spine Corporation (“Aurora Spine” or the “Company”) (TSXV: ASG) (OTCQB: ASAPF),…
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Spine
Altus Spine Announces FDA Clearance of Monaco HA Pedicle Screw System
West Chester, PA – May 31, 2022 /OrthosSpineNews/ – Altus Spine, a leader in the development and innovation of medical devices…
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Regulatory
SI-BONE, Inc. Receives FDA 510(k) Clearance for iFuse Bedrock Granite, a Breakthrough Pelvic Fixation and Fusion Technology
SANTA CLARA, Calif., May 31, 2022 (GLOBE NEWSWIRE) — SI-BONE, Inc., (Nasdaq: SIBN), a Silicon Valley-based medical device company dedicated to…
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Spine
Stryker Receives FDA Clearance for Q Guidance System for Spine Applications
Innovative planning and intraoperative platform designed to be a procedural ecosystem for surgeons and their patients during image-guided surgery May…
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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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