K061954 is an FDA 510(k) clearance for the ARTELON CMC SPACER ARTHRO. This device is classified as a Prosthesis, Wrist, Carpal Trapezium (Class II - Special Controls, product code KYI).
Submitted by Artimplant AB (Washington, US). The FDA issued a Cleared decision on June 1, 2007, 325 days after receiving the submission on July 11, 2006.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3770.
| 510(k) Number | K061954 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 11, 2006 |
| Decision Date | June 01, 2007 |
| Days to Decision | 325 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KYI — Prosthesis, Wrist, Carpal Trapezium |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3770 |