K180744 is an FDA 510(k) clearance for the Stablyx CMC Arthroplasty Implant System. 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 April 11, 2018, 20 days after receiving the submission on March 22, 2018.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3770.
| 510(k) Number | K180744 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 22, 2018 |
| Decision Date | April 11, 2018 |
| Days to Decision | 20 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 |