The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Zimmer Patellofemoral Joint Prosthesis.
| Device ID | K070695 |
| 510k Number | K070695 |
| Device Name: | ZIMMER PATELLOFEMORAL JOINT PROSTHESIS |
| Classification | Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Dalene Binkley |
| Correspondent | Dalene Binkley ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Product Code | KRR |
| CFR Regulation Number | 888.3540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-13 |
| Decision Date | 2007-06-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024205901 | K070695 | 000 |
| 00889024205826 | K070695 | 000 |
| 00889024205833 | K070695 | 000 |
| 00889024205840 | K070695 | 000 |
| 00889024205857 | K070695 | 000 |
| 00889024205864 | K070695 | 000 |
| 00889024205871 | K070695 | 000 |
| 00889024205888 | K070695 | 000 |
| 00889024205895 | K070695 | 000 |
| 00889024205819 | K070695 | 000 |