The following data is part of a premarket notification filed by Arthrex Inc. with the FDA for Univers Revers Humeral Cup Implant.
| Device ID | K221232 |
| 510k Number | K221232 |
| Device Name: | Univers Revers Humeral Cup Implant |
| Classification | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| 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 | HSD |
| CFR Regulation Number | 888.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-29 |
| Decision Date | 2022-05-19 |