Biomet is one of 20314 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Biomet - FDA 510(k) Cleared Devices
Recent clearances: MODIFIED DISTAL RADIUS PLATING SYSTEM, DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROW
2
Total
2
Cleared
0
Denied
Biomet, is an orthopedic medical device manufacturer with a manufacturing facility in Warsaw, US. The company specializes in orthopedic surgical implants and fixation systems for trauma and reconstructive procedures.
Biomet received 2 FDA 510(k) clearances from 2 total submissions between 2013 and 2014. The company's cleared devices focused on distal radius plating systems for wrist fracture fixation. This regulatory record reflects the company's historical activity in orthopedic trauma solutions.
The company is inactive and has not received FDA 510(k) clearances in more than a decade. This profile serves as a historical regulatory record. For detailed information on specific device names, product codes, and clearance dates, consult the FDA 510(k) database.
FDA 510(k) Regulatory Record - Biomet
2 devices