The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Oxford Fixed Lateral Bearing Partial Knee Replacement (oxford Tibial Trays A-f) Ixford Partial Knee Replacement System.
| Device ID | K122277 |
| 510k Number | K122277 |
| Device Name: | OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (OXFORD TIBIAL TRAYS A-F) IXFORD PARTIAL KNEE REPLACEMENT SYSTEM |
| Classification | Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer |
| Applicant | BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Elizabeth Wray |
| Correspondent | Elizabeth Wray BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | HRY |
| CFR Regulation Number | 888.3530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-30 |
| Decision Date | 2012-10-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304609884 | K122277 | 000 |
| 00880304543447 | K122277 | 000 |
| 00880304543430 | K122277 | 000 |
| 00880304543423 | K122277 | 000 |
| 00887868485541 | K122277 | 000 |
| 00887868485534 | K122277 | 000 |
| 00887868485527 | K122277 | 000 |
| 00887868485510 | K122277 | 000 |
| 00887868485503 | K122277 | 000 |
| 00880304543461 | K122277 | 000 |
| 00880304543478 | K122277 | 000 |
| 00880304609877 | K122277 | 000 |
| 00880304609860 | K122277 | 000 |
| 00880304543546 | K122277 | 000 |
| 00880304543539 | K122277 | 000 |
| 00880304543522 | K122277 | 000 |
| 00880304543515 | K122277 | 000 |
| 00880304543508 | K122277 | 000 |
| 00880304543485 | K122277 | 000 |
| 00887868485497 | K122277 | 000 |