The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Univers Ii Shoulder Prosthesis.
| Device ID | K103466 |
| 510k Number | K103466 |
| Device Name: | ARTHREX UNIVERS II SHOULDER PROSTHESIS |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples, FL 34108 -1945 |
| Contact | Sally Foust, Rac |
| Correspondent | Sally Foust, Rac ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples, FL 34108 -1945 |
| Product Code | KWS |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-24 |
| Decision Date | 2010-12-22 |
| Summary: | summary |