K040889 is an FDA 510(k) clearance for the EXACTECH OPTETRAK UNICONDYLAR KNEE. This device is classified as a Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer (Class II - Special Controls, product code HRY).
Submitted by Exactech, Inc. (Gainesville, US). The FDA issued a Cleared decision on October 1, 2004, 179 days after receiving the submission on April 5, 2004.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3530.
| 510(k) Number | K040889 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 05, 2004 |
| Decision Date | October 01, 2004 |
| Days to Decision | 179 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 |