ARTHREX UNIVERS II CA HEADS
Device Facts
| Record ID | K130675 |
|---|---|
| Device Name | ARTHREX UNIVERS II CA HEADS |
| Applicant | Arthrex, Inc. |
| Product Code | HSD · Orthopedic |
| Decision Date | Oct 30, 2013 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3690 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium-molybdenum. It has an intramedullary stem and is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed without bone cement (§ 888.3027). This device is not intended for biological fixation.
