K111068 is an FDA 510(k) clearance for the STABLYX CMC ARTHROPLASTY IMPLANT MODEL SIZES 1, 2, 3, 4, AND 5. This device is classified as a Prosthesis, Wrist, Carpal Trapezium (Class II - Special Controls, product code KYI).
Submitted by Skeletal Dynamics, LLC (Miami, US). The FDA issued a Cleared decision on December 30, 2011, 256 days after receiving the submission on April 18, 2011.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3770.
| 510(k) Number | K111068 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 18, 2011 |
| Decision Date | December 30, 2011 |
| Days to Decision | 256 days |
| Submission Type | Traditional |
| 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 |