K925613 is an FDA 510(k) clearance for the PROXIMAL HUMERAL REPLACEMENT SYSTEM. This device is classified as a Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented (Class II - Special Controls, product code KWT).
Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on October 14, 1994, 708 days after receiving the submission on November 5, 1992.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3650.
| 510(k) Number | K925613 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 05, 1992 |
| Decision Date | October 14, 1994 |
| Days to Decision | 708 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KWT — Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3650 |