KWB · Prosthesis, Hip, Hemi-, Acetabular, Cemented, Metal
Orthopedic · 21 CFR 888.3370 · Class 3
Overview
| Product Code | KWB |
|---|---|
| Device Name | Prosthesis, Hip, Hemi-, Acetabular, Cemented, Metal |
| Regulation | 21 CFR 888.3370 |
| Device Class | Class 3 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
A hip joint (hemi-hip) acetabular metal cemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have an acetabular component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).
Classification Rationale
Class III.
Cleared Devices (0)
No cleared devices on record.
