The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Biax A.f. Wrist/biax Advanced Fixation Wrist.
| Device ID | K031203 |
| 510k Number | K031203 |
| Device Name: | BIAX A.F. WRIST/BIAX ADVANCED FIXATION WRIST |
| Classification | Prosthesis, Wrist, 3 Part Metal-plastic-metal Articulation, Semi-constrained |
| 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 | JWJ |
| CFR Regulation Number | 888.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-16 |
| Decision Date | 2003-07-14 |
| Summary: | summary |