510(k) clearance
-
Recon
Corin Earns 510(k) Clearance for Unity Knee™ MC Tibial Insert, Compatible with ApolloKnee™
This latest enhancement to Corin’s Unity Knee™ portfolio will provide surgeons with the option to independently stabilize the medial compartment…
Read More » -
Recon
Best-in-class just got better; Smith+Nephew announces 510(k) clearance of new CATALYSTEM™ Primary Hip System
Engineered for precision, confidence and efficiency in surgery – and compatible with the CORI◊ Surgical System Smith+Nephew (LSE:SN, NYSE:SNN), the global…
Read More » -
Top Stories
Orthofix Announces 510(k) Clearance and First Implant of Fitbone Transport and Lengthening System
LEWISVILLE, Texas, July 9, 2024–(BUSINESS WIRE)–Orthofix Medical Inc. (NASDAQ:OFIX), a leading global spine and orthopedics company, today announced the 510(k)…
Read More » -
Regulatory
Spineart Receives 510(k) Clearance for SCARLET® AC-Ti Anterior Cervical Cage
GENEVA, May 28, 2024 /PRNewswire/ — Spineart, a fast-growing company specialized in spine surgery, proudly announces the 510(k) clearance from the U.S.…
Read More » -
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,…
Read More » -
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.…
Read More » -
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…
Read More » -
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…
Read More » -
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…
Read More » -
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…
Read More » -
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…
Read More » -
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…
Read More » -
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…
Read More » -
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…
Read More » -
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…
Read More »