The following data is part of a premarket notification filed by Shoulder Innovations, Inc. with the FDA for Inset Reverse Total Shoulder System.
Device ID | K210533 |
510k Number | K210533 |
Device Name: | Inset Reverse Total Shoulder System |
Classification | Shoulder Prosthesis, Reverse Configuration |
Applicant | Shoulder Innovations, Inc. 13827 Port Sheldon Street Holland, MI 49424 |
Contact | Don Running |
Correspondent | Don Running Shoulder Innovations, Inc. 13827 Port Sheldon Street Holland, MI 49424 |
Product Code | PHX |
CFR Regulation Number | 888.3660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-02-24 |
Decision Date | 2021-08-20 |