K853250 is an FDA 510(k) clearance for the FEMOROTIBIAL MEDULLARY NAIL. This device is classified as a Rod, Fixation, Intramedullary And Accessories (Class II - Special Controls, product code HSB).
Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on February 12, 1986, 195 days after receiving the submission on August 1, 1985.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3020.
| 510(k) Number | K853250 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 01, 1985 |
| Decision Date | February 12, 1986 |
| Days to Decision | 195 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | HSB — Rod, Fixation, Intramedullary And Accessories |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3020 |