K061146 is an FDA 510(k) clearance for the SBI ULNAR HEAD IMPLANT. This device is classified as a Prosthesis, Wrist, Hemi-, Ulnar (Class II - Special Controls, product code KXE).
Submitted by Small Bone Innovations, Inc. (New York, US). The FDA issued a Cleared decision on July 19, 2006, 85 days after receiving the submission on April 25, 2006.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3810.
| 510(k) Number | K061146 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 25, 2006 |
| Decision Date | July 19, 2006 |
| Days to Decision | 85 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KXE — Prosthesis, Wrist, Hemi-, Ulnar |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3810 |