K043431 is an FDA 510(k) clearance for the GAMMA3 NAIL SYSTEM. This device is classified as a Rod, Fixation, Intramedullary And Accessories (Class II - Special Controls, product code HSB).
Submitted by Howmedica Osteonics Corp. (Mahwah, US). The FDA issued a Cleared decision on February 16, 2005, 65 days after receiving the submission on December 13, 2004.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3020.
| 510(k) Number | K043431 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 13, 2004 |
| Decision Date | February 16, 2005 |
| Days to Decision | 65 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HSB — Rod, Fixation, Intramedullary And Accessories |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3020 |