K062903 is an FDA 510(k) clearance for the SBI CARPAL FUSION PLATE. This device is classified as a Plate, Fixation, Bone (Class II - Special Controls, product code HRS).
Submitted by Small Bone Innovations, Inc. (New York, US). The FDA issued a Cleared decision on October 20, 2006, 23 days after receiving the submission on September 27, 2006.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K062903 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 27, 2006 |
| Decision Date | October 20, 2006 |
| Days to Decision | 23 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HRS — Plate, Fixation, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |