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 |