The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Focus Cobalt Chromium Total Hip.
| Device ID | K904351 |
| 510k Number | K904351 |
| Device Name: | FOCUS COBALT CHROMIUM TOTAL HIP |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | DEPUY, INC. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Contact | David Kotkovetz |
| Correspondent | David Kotkovetz DEPUY, INC. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-24 |
| Decision Date | 1990-10-17 |