The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Depuy Endurance Calcar Hip Prosthesis.
| Device ID | K961619 |
| 510k Number | K961619 |
| Device Name: | DEPUY ENDURANCE CALCAR HIP PROSTHESIS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | DEPUY, INC. 700 ORTHOPAEDIC DR. Warsaw, IN 46581 -0988 |
| Contact | Cherly Hastings |
| Correspondent | Cherly Hastings DEPUY, INC. 700 ORTHOPAEDIC DR. Warsaw, IN 46581 -0988 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-26 |
| Decision Date | 1996-07-12 |
| Summary: | summary |