The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Depuy Asr Resurfacing Femoral Heads.
| Device ID | K032659 |
| 510k Number | K032659 |
| Device Name: | DEPUY ASR RESURFACING FEMORAL HEADS |
| Classification | Prosthesis, Hip, Femoral, Resurfacing |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Contact | Natalie Heck |
| Correspondent | Natalie Heck DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Product Code | KXA |
| CFR Regulation Number | 888.3400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-28 |
| Decision Date | 2003-12-04 |
| Summary: | summary |