Biomet UK, Ltd. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Biomet UK, Ltd. - FDA 510(k) Cleared Devices
Recent clearances: Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR Labeling, Biolox delta Ceramic Heads, Biolox delta Option Ceramic Heads
3
Total
3
Cleared
0
Denied
Biomet UK, Ltd. is an orthopedic device manufacturer with a registered facility in Warsaw, US. Now part of Zimmer Biomet, the brand continues to operate under the parent company's global musculoskeletal platform.
The company has received 3 FDA 510(k) clearances from 3 total submissions. All submissions focused on orthopedic devices, with clearances spanning 2014 to 2020. The company is currently inactive, with no new clearances recorded in the past five years.
Historical cleared devices include ceramic femoral heads and partial knee replacement bearing systems. These products reflect the company's core expertise in joint reconstruction and orthopedic implant technologies.
Explore the complete regulatory record, including specific device names, product codes, and individual clearance dates in the database.
FDA 510(k) Regulatory Record - Biomet UK, Ltd.
3 devices
Cleared
Jul 29, 2020
Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR Labeling
Orthopedic
110d
Cleared
Feb 27, 2020
Biolox delta Ceramic Heads, Biolox delta Option Ceramic Heads
Orthopedic
154d
Cleared
Mar 28, 2014
OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEARINGS / TRAYS)
Orthopedic
95d