K792650 is an FDA 510(k) clearance for the HAMAS PRECENTERED TOTAL 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 Zimmer, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 28, 1980, 38 days after receiving the submission on December 21, 1979.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3800.
| 510(k) Number | K792650 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 21, 1979 |
| Decision Date | January 28, 1980 |
| Days to Decision | 38 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| 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 |