21 CFR 888.3400 — Prosthesis, Hip, Femoral, Resurfacing
Orthopedic (OR) · Part 888 Subpart D—Prosthetic Devices · § 888.3400
Identification
A hip joint femoral (hemi-hip) metallic resurfacing 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 a femoral resurfacing component made of alloys, such as cobalt-chromium-molybdenum.
Classification Rationale
Class II.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| KXA | Prosthesis, Hip, Femoral, Resurfacing | 2 | 23 | Implant |
