K011138 is an FDA 510(k) clearance for the OXFORD UNICOMPARTMENTAL KNEE FEMORAL COMPONENT. This device is classified as a Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer (Class II - Special Controls, product code HRY).
Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on July 10, 2001, 88 days after receiving the submission on April 13, 2001.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3530.
| 510(k) Number | K011138 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 13, 2001 |
| Decision Date | July 10, 2001 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HRY — Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3530 |