ISS OFFSET HEADS
Device Facts
| Record ID | K003428 |
|---|---|
| Device Name | ISS OFFSET HEADS |
| Applicant | Biomet, Inc. |
| Product Code | HSD · Orthopedic |
| Decision Date | Nov 24, 2000 |
| Decision | SESE |
| Submission Type | Special |
| 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.
