KWJ · Prosthesis, Elbow, Hemi-, Humeral, Metal
Orthopedic · 21 CFR 888.3180 · Class 3
Overview
| Product Code | KWJ |
|---|---|
| Device Name | Prosthesis, Elbow, Hemi-, Humeral, Metal |
| Regulation | 21 CFR 888.3180 |
| Device Class | Class 3 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
An elbow joint humeral (hemi-elbow) metallic uncemented prosthesis is a device intended to be implanted made of alloys, such as cobalt-chromium-molybdenum, that is used to replace the distal end of the humerus formed by the trochlea humeri and the capitulum humeri. The generic type of device is limited to prostheses intended for use without bone cement (§ 888.3027).
Classification Rationale
Class III.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
