K060038 is an FDA 510(k) clearance for the SBI RADIO-CAPITELLAR IMPLANT. This device is classified as a Prosthesis, Elbow, Semi-constrained, Cemented (Class II — Special Controls, product code JDB).
Submitted by Small Bone Innovations, Inc. (New York, US). The FDA issued a Cleared decision on March 30, 2006, 83 days after receiving the submission on January 6, 2006.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3160.
| 510(k) Number | K060038 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 06, 2006 |
| Decision Date | March 30, 2006 |
| Days to Decision | 83 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | JDB — Prosthesis, Elbow, Semi-constrained, Cemented |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 888.3160 |