K864788 is an FDA 510(k) clearance for the EXACTECH TOTAL HIP INSTRUMENTS..
Submitted by Exactech, Inc. (Gainesville, US). The FDA issued a Cleared decision on December 29, 1986, 21 days after receiving the submission on December 8, 1986.
This device falls under the Orthopedic FDA review panel.
| 510(k) Number | K864788 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 08, 1986 |
| Decision Date | December 29, 1986 |
| Days to Decision | 21 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | — |
| Device Class | — |