The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Oxford Unicompartmental Knee Femoral Component.
| Device ID | K011138 |
| 510k Number | K011138 |
| Device Name: | OXFORD UNICOMPARTMENTAL KNEE FEMORAL COMPONENT |
| Classification | Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer |
| Applicant | BIOMET, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Patricia S Beres |
| Correspondent | Patricia S Beres BIOMET, INC. 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 | 2001-04-13 |
| Decision Date | 2001-07-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304180604 | K011138 | 000 |
| 00880304180598 | K011138 | 000 |
| 00880304180581 | K011138 | 000 |
| 00880304180574 | K011138 | 000 |