KYM · Metallic Cemented Glenoid Hemi-Shoulder Prosthesis
Orthopedic · 21 CFR 888.3680 · Class 3
Overview
| Product Code | KYM |
|---|---|
| Device Name | Metallic Cemented Glenoid Hemi-Shoulder Prosthesis |
| Regulation | 21 CFR 888.3680 |
| Device Class | Class 3 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
A shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis is a device that has a glenoid (socket) component made of alloys, such as cobalt-chromium-molybdenum, or alloys with ultra-high molecular weight polyethylene and intended to be implanted to replace part of a shoulder joint. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).
Classification Rationale
Class III.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
