K960538 is an FDA 510(k) clearance for the OPTEON UNIPOLAR. This device is classified as a Prosthesis, Hip, Hemi-, Femoral, Metal (Class II - Special Controls, product code KWL).
Submitted by Exactech, Inc. (Gainesville, US). The FDA issued a Cleared decision on March 27, 1996, 49 days after receiving the submission on February 7, 1996.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3360.
| 510(k) Number | K960538 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 07, 1996 |
| Decision Date | March 27, 1996 |
| Days to Decision | 49 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KWL — Prosthesis, Hip, Hemi-, Femoral, Metal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3360 |