The following data is part of a premarket notification filed by Howmedica Osteonics Corp with the FDA for Avon Patello-femoral Joint Prosthesis.
| Device ID | K051948 |
| 510k Number | K051948 |
| Device Name: | AVON PATELLO-FEMORAL JOINT PROSTHESIS |
| Classification | Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer |
| Applicant | HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
| Contact | Vivian Kelly |
| Correspondent | Vivian Kelly HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
| Product Code | KRR |
| CFR Regulation Number | 888.3540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-18 |
| Decision Date | 2005-10-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327048131 | K051948 | 000 |
| 07613327048124 | K051948 | 000 |
| 07613327046748 | K051948 | 000 |