K103374 is an FDA 510(k) clearance for the INBONE TOTAL ANKLE SYSTEM MODEL 200347902. This device is classified as a Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer (Class II - Special Controls, product code HSN).
Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on December 14, 2010, 27 days after receiving the submission on November 17, 2010.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3110.
| 510(k) Number | K103374 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 17, 2010 |
| Decision Date | December 14, 2010 |
| Days to Decision | 27 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HSN — Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3110 |