21 CFR 888.3770 — Prosthesis, Wrist, Carpal Trapezium
Orthopedic (OR) · Part 888 Subpart D—Prosthetic Devices · § 888.3770
Identification
A wrist joint carpal trapezium polymer prosthesis is a one-piece device made of silicone elastomer or silicone elastomer/polyester material intended to be implanted to replace the carpal trapezium bone of the wrist.
Classification Rationale
Class II.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| KYI | Prosthesis, Wrist, Carpal Trapezium | 2 | 26 | Implant |