The following data is part of a premarket notification filed by Medacta International, Sa with the FDA for Medacta Shoulder System.
Device ID | K192967 |
510k Number | K192967 |
Device Name: | Medacta Shoulder System |
Classification | Shoulder Prosthesis, Reverse Configuration |
Applicant | Medacta International, SA Strada Regina Castel San Pietro, CH 6874 |
Contact | Stefano Baj |
Correspondent | Chris Lussier Medacta USA 3973 Delp Street Memphis, TN 38118 |
Product Code | PHX |
Subsequent Product Code | HSD |
Subsequent Product Code | KWS |
Subsequent Product Code | KWT |
CFR Regulation Number | 888.3660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-10-23 |
Decision Date | 2020-03-25 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07630040733960 | K192967 | 000 |
07630040734066 | K192967 | 000 |
07630040734059 | K192967 | 000 |
07630040734042 | K192967 | 000 |
07630040734035 | K192967 | 000 |
07630040734028 | K192967 | 000 |
07630040734011 | K192967 | 000 |
07630040734004 | K192967 | 000 |
07630040733991 | K192967 | 000 |
07630040733984 | K192967 | 000 |
07630040734073 | K192967 | 000 |
07630040734080 | K192967 | 000 |
07630040733953 | K192967 | 000 |
07630040733946 | K192967 | 000 |
07630040733939 | K192967 | 000 |
07630040733922 | K192967 | 000 |
07630040734134 | K192967 | 000 |
07630040734127 | K192967 | 000 |
07630040734110 | K192967 | 000 |
07630040734103 | K192967 | 000 |
07630040734097 | K192967 | 000 |
07630040733977 | K192967 | 000 |