The following data is part of a premarket notification filed by Medacta International Sa with the FDA for Humeral Eccentric Reverse Metaphysis.
Device ID | K210207 |
510k Number | K210207 |
Device Name: | Humeral Eccentric Reverse Metaphysis |
Classification | Shoulder Prosthesis, Reverse Configuration |
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 | PHX |
Subsequent Product Code | KWS |
Subsequent Product Code | MBF |
CFR Regulation Number | 888.3660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-01-26 |
Decision Date | 2021-03-26 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07630345716781 | K210207 | 000 |