21 CFR 888.3760 — Prosthesis, Wrist, Carpal Scaphoid
Orthopedic (OR) · Part 888 Subpart D—Prosthetic Devices · § 888.3760
Identification
A wrist joint carpal scaphoid polymer prosthesis is a one-piece device made of silicone elastomer intended to be implanted to replace the carpal scaphoid bone of the wrist.
Classification Rationale
Class II.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| KWO | Prosthesis, Wrist, Carpal Scaphoid | 2 | 1 | Implant |
