The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Univers Ii Shoulder Prosthesis.
| Device ID | K071032 |
| 510k Number | K071032 |
| Device Name: | ARTHREX UNIVERS II SHOULDER PROSTHESIS |
| Classification | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| Applicant | ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples, FL 34108 -1945 |
| Contact | Nancy Hoft |
| Correspondent | Nancy Hoft ARTHREX, INC. 1370 CREEKSIDE BLVD. 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 | 2007-04-11 |
| Decision Date | 2007-08-20 |
| Summary: | summary |