K031203 is an FDA 510(k) clearance for the BIAX A.F. WRIST/BIAX ADVANCED FIXATION WRIST. This device is classified as a Prosthesis, Wrist, 3 Part Metal-plastic-metal Articulation, Semi-constrained (Class II - Special Controls, product code JWJ).
Submitted by DePuy Orthopaedics, Inc. (Warsaw, US). The FDA issued a Cleared decision on July 14, 2003, 89 days after receiving the submission on April 16, 2003.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3800.
| 510(k) Number | K031203 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 16, 2003 |
| Decision Date | July 14, 2003 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | JWJ - Prosthesis, Wrist, 3 Part Metal-plastic-metal Articulation, Semi-constrained |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3800 |