K845025 is an FDA 510(k) clearance for the AUSTIN-MOORE MODULAR HIP PROSTHESIS. This device is classified as a Prosthesis, Hip, Hemi-, Femoral, Metal (Class II - Special Controls, product code KWL).
Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on April 19, 1985, 113 days after receiving the submission on December 27, 1984.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3360.
| 510(k) Number | K845025 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 27, 1984 |
| Decision Date | April 19, 1985 |
| Days to Decision | 113 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | KWL — Prosthesis, Hip, Hemi-, Femoral, Metal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3360 |