K864631 is an FDA 510(k) clearance for the MOORE'S STRAIGHT & THOMPSON'S CURVED STEM PROSTHE...
Submitted by Downs Surgical , Ltd. (Mitcham Surrey, GB). The FDA issued a Cleared decision on December 18, 1986, 23 days after receiving the submission on November 25, 1986.
This device falls under the Orthopedic FDA review panel.
| 510(k) Number | K864631 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 25, 1986 |
| Decision Date | December 18, 1986 |
| Days to Decision | 23 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | — |
| Device Class | — |