K073635 is an FDA 510(k) clearance for the SBI SR MTP TOE IMPLANT. This device is classified as a Prosthesis, Toe, Hemi-, Phalangeal (Class II - Special Controls, product code KWD).
Submitted by Small Bone Innovations, Inc. (Washington, US). The FDA issued a Cleared decision on March 19, 2008, 84 days after receiving the submission on December 26, 2007.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3730.
| 510(k) Number | K073635 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 26, 2007 |
| Decision Date | March 19, 2008 |
| Days to Decision | 84 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 |