K201072 is an FDA 510(k) clearance for the Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161. This device is classified as a Prosthesis, Wrist, Carpal Trapezium (Class II - Special Controls, product code KYI).
Submitted by Ensemble Orthopedics, LLC (Austin, US). The FDA issued a Cleared decision on December 2, 2020, 224 days after receiving the submission on April 22, 2020.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3770.
| 510(k) Number | K201072 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 22, 2020 |
| Decision Date | December 02, 2020 |
| Days to Decision | 224 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 |