FDA 510(k) Clearance
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Extremities
Tyber Medical Receives FDA Clearance on Plating System Line Extension
Tyber Medical Broadens Its Vast Plating Portfolio with FDA Approval of Additional Screw and Plate Options, and Indications for Mini-Frag…
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Extremities
Tyber Medical Granted FDA Clearance on Distal Radius Plating System
Tyber Medical Expands Its Extensive Plating Portfolio with FDA Approval of Distal Radius Plating System for Fractured Radius, Ulna and…
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Regulatory
Spinal Simplicity Announces 510(K) FDA Clearance of Its Novel Sacroiliac Joint System, the Liberty-SI Lateral Implant
Spinal Simplicity’s Liberty-SI Lateral Implant System is a revolutionary sacroiliac joint fusion technology designed for safer and potentially less invasive…
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Regulatory
POLARIS AR Receives Clearance From The U.S. Food And Drug Administration For STELLAR Knee
MIAMI, Nov. 3, 2023 /PRNewswire/ — POLARISAR is pleased to announce today that their STELLAR Knee has received 510(k) clearance from the U.S.…
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Regulatory
Spineway-VEOS FDA 510(k) clearance
Spineway obtains 510(k) clearance from the FDAfor its VEOS spinal fixation system Ecully, October 19, 2023- Spineway Group, a specialist…
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Regulatory
Stryker’s Pangea Systems Receive FDA Clearance
Pangea to offer a comprehensive and versatile portfolio, providing variable-angle plating for a variety of patient populations KALAMAZOO, Mich., September…
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Extremities
OrthoPediatrics Corp. Receives FDA 510(k) Clearance for Pediatric Nailing Platform | Tibia
WARSAW, Ind., Sept. 11, 2023 (GLOBE NEWSWIRE) — OrthoPediatrics Corp. (“OrthoPediatrics”) (NASDAQ: KIDS), a company focused exclusively on advancing the field of…
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