510(k) clearance
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Recon
Corin Group Attains 510(k) Clearance for Apollo™ Platform: Revolutionizing Robotic-Assisted Total Knee Arthroplasty
CIRENCESTER, UNITED KINGDOM, November 1, 2023 / EINPresswire.com / — Corin Group, an innovator in the field of orthopaedic procedures,…
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Spine
4WEB Medical Receives 510k Clearance to Market New Integrated Cervical Plate
4WEB’s Cervical Spine Truss System (CSTS) Integrated Plating Solution Company Continues to Build Momentum with Most Recent Portfolio Expansion. DALLAS, Sept.…
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Biologics
Collagen Matrix, Inc. Announces 510(k) Clearance for Fibrillar Collagen Wound Dressing, Expanding Offerings for Advanced Wound Market
OAKLAND, N.J., June 28, 2022 /PRNewswire/ — Collagen Matrix, Inc., a leader in regenerative medicine, global manufacturer of collagen and other biomaterial-based medical…
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Spine
Life Spine Announces Additional 510(k) Clearance for SImpact® SI Joint Fixation System
March 29, 2022 HUNTLEY, Ill.–(BUSINESS WIRE)–Life Spine, a medical device company that designs, develops, manufactures and markets products for the…
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Biologics
Biorez Announces FDA 510(k) Clearance of Its Proprietary BioBrace™ Implant Technology
The BioBrace implant represents the first biocomposite soft tissue scaffold designed to reinforce tendon and ligament repairs, promote healing, and…
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Regulatory
4WEB Medical Receives 510(k) Clearance for its Lumbar Plating Solution
DALLAS, March 17, 2021 /PRNewswire/ — 4WEB Medical, an orthopedic device company focused on developing innovative implants with an Advanced Structural Design utilizing…
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Regulatory
Fusion Robotics™ Receives 510(k) Clearance for Spinal Navigation & Robotics System
BOULDER, Colo., Feb. 25, 2021 /PRNewswire/ — Fusion Robotics LLC, a spinal robotics and navigation company today announced receiving 510(k) clearance to…
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Recon
LimaCorporate Receives Regulatory Approvals For Smart Space Digital Platform
SAN DANIELE DEL FRIULI, Italy, Feb. 11, 2021 /PRNewswire/ — LimaCorporate makes important strides in the development of its digital platform designed to assist…
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Biologics
Nanovis Awarded 510(k) for Nano FortiFix® the First Nanotechnology Enhanced Pedicle Screw System
CARMEL, Ind., April 23, 2020 /PRNewswire/ — Nanovis today announced that it received 510(k) clearance for a bioceramic nanotube surface on its Nano FortiFix…
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Hospitals
Zimmer Biomet Announces 510(k) Clearance for Zyston® Strut Open Titanium Interbody Spacer System
WARSAW, Ind., May 22, 2018 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced…
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Hospitals
Mobius Imaging Receives 510(k) Clearance for Airo® CT Pediatric Applications
SHIRLEY, Mass., April 26, 2018 /PRNewswire/ — Mobius Imaging, LLC, announced today that it has received 510(k) clearance for its Airo® Mobile CT Imaging…
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Hospitals
Exactech Receives 510(k) Clearance for Equinoxe® Stemless Shoulder
March 12, 2018 GAINESVILLE, Fla.–(BUSINESS WIRE)–Exactech, a leading developer and producer of bone and joint restoration products and biologic solutions…
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Hospitals
Xtant Medical Receives 510k Clearance for Expanded Indications of Irix-A
BELGRADE, Mont., Sept. 12, 2017 (GLOBE NEWSWIRE) — Xtant Medical Holdings, Inc. (NYSE American:XTNT), a leader in the development of…
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Biologics
Kuros receives clearance for MagnetOs Putty for commercialization in the United States and files the product for CE marking in Europe
Schlieren (Zurich), Switzerland, August 28, 2017 – Kuros Biosciences announced today that it has received 510(k) clearance from the US…
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Spine
K2M First-to-Market with 3D-Printed Corpectomy Cage System Following FDA Clearance of CAPRI™ Small 3D Static Featuring Lamellar 3D Titanium Technology™
LEESBURG, Va., June 28, 2017 (GLOBE NEWSWIRE) — K2M Group Holdings, Inc. (NASDAQ:KTWO) (the “Company” or “K2M”), a global leader…
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