K912930 is an FDA 510(k) clearance for the INTERLOCKING FEMORAL NAILING SYSTEM. This device is classified as a Rod, Fixation, Intramedullary And Accessories (Class II - Special Controls, product code HSB).
Submitted by Stryker Corp. (Kalamazoo, US). The FDA issued a Cleared decision on January 13, 1992, 192 days after receiving the submission on July 5, 1991.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3020.
| 510(k) Number | K912930 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 05, 1991 |
| Decision Date | January 13, 1992 |
| Days to Decision | 192 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Statement |
| Product Code | HSB — Rod, Fixation, Intramedullary And Accessories |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3020 |