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 | K191960 |
| 510k Number | K191960 |
| Device Name: | Arthrex Univers Revers Modular Glenoid System |
| Classification | Shoulder Prosthesis, Reverse Configuration |
| Applicant | Arthrex Inc. 1370 Creekside Boulevard Naples, FL 34108 -1945 |
| Contact | Ivette Galmez |
| Correspondent | Ivette Galmez Arthrex Inc. 1370 Creekside Boulevard Naples, FL 34108 -1945 |
| Product Code | PHX |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-23 |
| Decision Date | 2019-12-23 |
| Summary: | summary |