The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Universii Xl Glenoid-pegged, Arthrex Univers Ii Xl Glenoid-keeled.
| Device ID | K120044 |
| 510k Number | K120044 |
| Device Name: | ARTHREX UNIVERSII XL GLENOID-PEGGED, ARTHREX UNIVERS II XL GLENOID-KEELED |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples, FL 34108 -1945 |
| Contact | Courtney Smith |
| Correspondent | Courtney Smith 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 | 2012-01-05 |
| Decision Date | 2012-03-08 |
| Summary: | summary |