K843778 is an FDA 510(k) clearance for the MAYO ELBOW II..
Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on March 5, 1985, 161 days after receiving the submission on September 25, 1984.
This device falls under the Orthopedic FDA review panel.
| 510(k) Number | K843778 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 25, 1984 |
| Decision Date | March 05, 1985 |
| Days to Decision | 161 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | — |
| Device Class | — |