FDA (510)k Clearance
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Recon
Implanet Announces FDA 510(k) Clearance for the MADISON Total Knee Prosthesis
October 29, 2019 BORDEAUX, France & BOSTON–(BUSINESS WIRE)–Regulatory News: IMPLANET (Euronext Growth: ALIMP, FR0010458729, eligible for PEA-PME equity savings plans)…
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Regulatory
Nanovis Awarded Nanotechnology Designation for Bioceramic Nanotube Surface
CARMEL, IND. (PRWEB) OCTOBER 23, 2019 Nanovis today announced that it received the first 510(k) clearance for a bioceramic nanotube surface…
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Extremities
FDA Clears the Smart-C Advanced X-ray Imaging System from Turner Imaging Systems
October 02, 2019 OREM, Utah–(BUSINESS WIRE)–Turner Imaging Systems, a developer of advanced X-ray imaging systems, today announced the company has…
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Hospitals
3D Systems’ VSP Orthopaedics Receives FDA 510(k) Clearance — Opening the Door to Personalized Treatment of Complex Musculoskeletal Disease
ROCK HILL, S.C., Sept. 26, 2019 /PRNewswire/ — 3D Systems (NYSE: DDD) announced that the Food and Drug Administration (FDA) has provided 510(k) clearance to…
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Spine
Omnia Medical Receives First Ever 510(k) Clearance for PEEK-OPTIMA™ HA Enhanced Cervical VBR
US FDA 510(k) clearance paves the way for an innovative orthopedic product that offers the potential to improve bone apposition…
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Regulatory
FDA continues to take steps to fulfill its commitment to strengthen and modernize the 510(k) medical device program
SILVER SPRING, Md., Sept. 19, 2019 /PRNewswire/ — The U.S. Food and Drug Administration today announced that, as a first step toward…
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Recon
Zimmer Biomet Receives FDA Clearance of JuggerStitch™ Meniscal Repair Device
WARSAW, Ind., Sept. 16, 2019 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, has…
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Regulatory
Atlas Spine Receives 510K Clearance for its V3 Guided Segmental Cervical Plating System
JUPITER, FL, September 16, 2019 — Atlas Spine Inc., a spinal implant company based in Jupiter Florida, announced today the…
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Recon
Zimmer Biomet Commences Commercial Release of Persona® Revision Knee System
WARSAW, Ind., Sept. 9, 2019 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today…
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Regulatory
4WEB Medical Announces FDA 510(k) Clearance of its Cervical Stand-Alone Interbody Fusion Device
DALLAS, Aug. 28, 2019 /PRNewswire/ — 4WEB Medical, an orthopedic device company focused on developing innovative implants utilizing its proprietary Truss Implant Technology™,…
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Regulatory
Karolinska Development’s portfolio company Promimic receives FDA approval for its HAnano Surface® on a spinal implant
STOCKHOLM – August 28, 2019. Karolinska Development’s portfolio company Promimic today announced that the company’s first spinal device utilizing HAnano Surface…
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Regulatory
Cutting Edge Spine Announces FDA 510(K) Clearance of its EVOL-SI Joint Fusion System; Bringing Novel Super Hydrophilic Nano-technology to the Sacral-iliac Fixation Market
WAXHAW, N.C. (PRWEB) AUGUST 20, 2019 Cutting Edge Spine, a leader in the organic development and commercialization of bioactive technologies for the…
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Extremities
OrthoPediatrics Corp. Receives FDA 510(k) Clearance for First Pediatric-Specific Foot System
WARSAW, Ind., Aug. 19, 2019 (GLOBE NEWSWIRE) — OrthoPediatrics Corp.(“OrthoPediatrics”) (NASDAQ: KIDS), a company focused exclusively on advancing the field of…
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Spine
Nexxt Spine Adds Stand Alone Cervical to the NEXXT MATRIXX® Family
August 06, 2019 NOBLESVILLE, Ind.–(BUSINESS WIRE)–Nexxt Spine LLC, a pioneer in the design and manufacturing of innovative spinal solutions, is…
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Regulatory
MiRus Receives FDA Clearance for Lowest Profile Anterior Cervical Plate System
ATLANTA, July 26, 2019 /PRNewswire/ — MiRus is pleased to announce recent FDA 510(k) clearance of the CYGNUS™ Anterior Cervical Plate System, the…
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