510(k) clearance
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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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Hospitals
Exactech Receives 510(k) Clearance for Computer-Assisted Shoulder Arthroplasty Technology
GAINESVILLE, Fla.–(BUSINESS WIRE)– May 15, 2017 Exactech, Inc. (EXAC), a developer and producer of bone and joint restoration products and…
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Hospitals
Joimax® Announces 510(k) Clearance for Its Endovapor® 2 Multi Radio Frequency System
April 26, 2017 IRVINE, Calif.–(BUSINESS WIRE)–joimax®, the German based market leader of technologies and training methods for endoscopic minimally invasive…
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