K984353 is an FDA 510(k) clearance for the OSTEO 9MM IC TIBIAL NAIL. This device is classified as a Rod, Fixation, Intramedullary And Accessories (Class II - Special Controls, product code HSB).
Submitted by Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on December 16, 1998, 9 days after receiving the submission on December 7, 1998.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3020.
| 510(k) Number | K984353 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 07, 1998 |
| Decision Date | December 16, 1998 |
| Days to Decision | 9 days |
| Submission Type | Special |
| 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 |