K080426 is an FDA 510(k) clearance for the MAESTRO WRIST FRACTURE IMPLANT. 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 Biomet Manufacturing Corp (Warsaw, US). The FDA issued a Cleared decision on July 29, 2008, 160 days after receiving the submission on February 20, 2008.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3800.
| 510(k) Number | K080426 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 20, 2008 |
| Decision Date | July 29, 2008 |
| Days to Decision | 160 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 |