The following data is part of a premarket notification filed by Medacta International Sa with the FDA for Mectaplug Pe Ii.
| Device ID | K210062 |
| 510k Number | K210062 |
| Device Name: | Mectaplug PE II |
| Classification | Prosthesis, Hip, Cement Restrictor |
| Applicant | Medacta International SA Strada Regina Castel San Pietro, CH Ch-6874 |
| Contact | Stefano Baj |
| Correspondent | Chris Lussier Medacta USA 3973 Delp Street Memphis, TN 83118 |
| Product Code | JDK |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-11 |
| Decision Date | 2021-04-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630345711007 | K210062 | 000 |
| 07630345710994 | K210062 | 000 |
| 07630345710987 | K210062 | 000 |
| 07630345710970 | K210062 | 000 |
| 07630345710963 | K210062 | 000 |