The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Univers Revers Shoulder Prosthesis System.
| Device ID | K161782 |
| 510k Number | K161782 |
| Device Name: | Arthrex Univers Revers Shoulder Prosthesis System |
| Classification | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| Applicant | ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples, FL 34108 -1945 |
| Contact | David L Rogers |
| Correspondent | David L Rogers ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples, FL 34108 -1945 |
| Product Code | HSD |
| CFR Regulation Number | 888.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-29 |
| Decision Date | 2016-11-21 |
| Summary: | summary |