K210062 is an FDA 510(k) clearance for the Mectaplug PE II. This device is classified as a Prosthesis, Hip, Cement Restrictor (Class II - Special Controls, product code JDK).
Submitted by Medacta International S.A. (Castel San Pietro (Ch), CH). The FDA issued a Cleared decision on April 8, 2021, 87 days after receiving the submission on January 11, 2021.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K210062 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 11, 2021 |
| Decision Date | April 08, 2021 |
| Days to Decision | 87 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | JDK — Prosthesis, Hip, Cement Restrictor |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3300 |