FDA (510)k Clearance
-
Regulatory
Restore Robotics Seeks FDA 510(k) Clearance for Remanufacturing Da Vinci Xi® 8mm Monopolar Curved Scissors
*Significant cost savings for hospitals and expanded sustainability initiatives with recycling program* PANAMA CITY BEACH, Fla., Oct. 16, 2024 /PRNewswire/ — Restore…
Read More » -
Spine
SpineGuard Obtains FDA Clearance for Commercial Release of Its “PsiFGuard” New Smart Drilling Device Dedicated to Sacroiliac Joint Fusion
Innovation developed in partnership with the US company Omnia Medical Key milestone for the deployment of the DSG® technology in the…
Read More » -
Extremities
Exactech Announces Clearance for Its New 3D-Printed Vantage® Ankle Tibial Implants
GAINESVILLE, Fla., October 26, 2023–(BUSINESS WIRE)–Exactech, a developer and producer of innovative implants, instrumentation, and smart technologies for joint replacement…
Read More » -
Recon
Onkos Surgical Receives FDA 510(k) Clearance for 3D Printed, Patient-Specific Pelvic Reconstruction System
Company expands its portfolio of musculoskeletal oncology and complex orthopaedic solutions to include conditions of the pelvis PARSIPPANY, N.J., July 14,…
Read More » -
Regulatory
Accelus Receives U.S. FDA 510(k) Clearance for its FlareHawk TiHawk11 Interbody Fusion System
PALM BEACH GARDENS, Fla., May 12, 2022 (GLOBE NEWSWIRE) — Accelus, a privately held medical technology company focused on accelerating…
Read More » -
Extremities
Nextremity Solutions, Inc. Receives FDA 510(k) Clearance for Subtalar Joint Fusion System
InCore line of products expands with latest addition. WARSAW, IND. (PRWEB) JANUARY 14, 2022 Nextremity Solutions, Inc., a strategic commercialization organization…
Read More » -
Regulatory
New View Surgical, Inc. Announces FDA Clearance of its VisionPort™ System for Minimally Invasive Surgery
The VisionPort™ is the first surgeon-controlled, multi-camera laparoscopic visualization system June 23, 2021 BOSTON–(BUSINESS WIRE)–New View Surgical, Inc., a medical…
Read More » -
Regulatory
Inspired Spine announces Trident™ SI Joint Screw System Secures FDA 510(k) Approval
BURNSVILLE, Minn., Jan. 26, 2021 /PRNewswire/ — Inspired Spine has announced the Trident SI Joint Screw System, manufactured by Advanced Research Medical (ARM),…
Read More » -
Spine
Nexxt Spine Rolls Out Corpectomy System to Surgeons
Top manufacturer of spinal solutions unleashes anticipated 3D printed titanium corpectomy cage to the market March 31, 2020- Noblesville, IN-…
Read More » -
Extremities
Gramercy Extremity Orthopedics® Receives FDA 510(k) Clearance for GEO FirstFuse MTPJ Fusion Plating System
RICHARDSON, TEXAS, UNITED STATES, March 30, 2020 /EINPresswire.com/ — Gramercy Extremity Orthopedics® (GEO) today announced it has received the U.S. Food…
Read More » -
Regulatory
OrthoPediatrics Corp. Receives FDA 510(k) Clearance and Expanded Neuromuscular Indications for its RESPONSE™ Scoliosis System
WARSAW, Ind., March 31, 2020 (GLOBE NEWSWIRE) — OrthoPediatrics Corp. (“OrthoPediatrics”) (Nasdaq: KIDS), a company focused exclusively on advancing the field of…
Read More » -
Extremities
New KinematX Total Wrist Arthroplasty from Extremity Medical
March 26, 2020 PARSIPPANY, N.J.–(BUSINESS WIRE)–Extremity Medical, a global medical device company with expertise in innovative implants for upper and…
Read More » -
Extremities
OSSIO Receives FDA 510(k) Clearance for OSSIOfiber® Hammertoe Fixation System
March 12, 2020 WOBURN, Mass.–(BUSINESS WIRE)–OSSIO, Inc., an orthopedic fixation company, today announced that its OSSIOfiber® Hammertoe Fixation System has…
Read More » -
Regulatory
CoNextions Inc. Announces FDA 510(k) Clearance of Coronet™ System, a Revolutionary Tenodesis Product
SALT LAKE CITY, March 12, 2020 /PRNewswire/ — CoNextions Inc. (www.conextionsmed.com) announced today that it received a 510(k) clearance (K200028) from the…
Read More » -
Biologics
Biogennix Receives FDA Clearance for Expanded Use of Agilon Moldable Bone Grafting Solution in Spine Procedures
March 04, 2020 IRVINE, Calif.–(BUSINESS WIRE)–Irvine-based Biogennix, an osteobiologics company that develops, manufactures, and distributes proprietary bone graft products used for…
Read More »