K852137 is an FDA 510(k) clearance for the FENLIN TOTAL SHOULDER..
Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on February 12, 1986, 272 days after receiving the submission on May 16, 1985.
This device falls under the Orthopedic FDA review panel.
| 510(k) Number | K852137 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 16, 1985 |
| Decision Date | February 12, 1986 |
| Days to Decision | 272 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | — |
| Device Class | — |