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.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
