K062040 is an FDA 510(k) clearance for the SBI TRIHEDRON MTP HEMI GT. This device is classified as a Prosthesis, Toe, Hemi-, Phalangeal (Class II - Special Controls, product code KWD).
Submitted by Small Bone Innovations, Inc. (New York, US). The FDA issued a Cleared decision on October 3, 2006, 76 days after receiving the submission on July 19, 2006.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3730.
| 510(k) Number | K062040 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 19, 2006 |
| Decision Date | October 03, 2006 |
| Days to Decision | 76 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KWD — Prosthesis, Toe, Hemi-, Phalangeal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3730 |