The following data is part of a premarket notification filed by Arthrex Inc. with the FDA for Arthrex Univers Revers Modular Glenoid System.
Device ID | K173900 |
510k Number | K173900 |
Device Name: | Arthrex Univers Revers Modular Glenoid System |
Classification | Shoulder Prosthesis, Reverse Configuration |
Applicant | Arthrex Inc. 1370 Creekside Boulevard Naples, FL 34108 -1945 |
Contact | Courtney Smith |
Correspondent | Courtney Smith Arthrex Inc. 1370 Creekside Boulevard Naples, FL 34108 -1945 |
Product Code | PHX |
CFR Regulation Number | 888.3660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-12-22 |
Decision Date | 2018-04-20 |
Summary: | summary |