The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Univers Rivers Shoulder Prosthesis System.
| Device ID | K142863 |
| 510k Number | K142863 |
| Device Name: | Univers Rivers Shoulder Prosthesis 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 | 2014-10-01 |
| Decision Date | 2014-11-25 |
| Summary: | summary |