The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Depuy C-stem Amt Hip Prosthesis.
| Device ID | K042959 |
| 510k Number | K042959 |
| Device Name: | DEPUY C-STEM AMT HIP PROSTHESIS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Contact | Dina L Weissman |
| Correspondent | Dina L Weissman DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-27 |
| Decision Date | 2004-12-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295060369 | K042959 | 000 |
| 10603295059615 | K042959 | 000 |
| 10603295059639 | K042959 | 000 |
| 10603295059646 | K042959 | 000 |
| 10603295059653 | K042959 | 000 |
| 10603295059660 | K042959 | 000 |
| 10603295059677 | K042959 | 000 |
| 10603295060291 | K042959 | 000 |
| 10603295060307 | K042959 | 000 |
| 10603295060321 | K042959 | 000 |
| 10603295060338 | K042959 | 000 |
| 10603295060345 | K042959 | 000 |
| 10603295060352 | K042959 | 000 |
| 10603295059608 | K042959 | 000 |