21 CFR 888.3750 — Prosthesis, Wrist, Carpal Lunate
Orthopedic (OR) · Part 888 Subpart D—Prosthetic Devices · § 888.3750
Identification
A wrist joint carpal lunate prosthesis is a one-piece device made of silicone elastomer intended to be implanted to replace the carpal lunate bone of the wrist.
Classification Rationale
Class II.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| KWN | Prosthesis, Wrist, Carpal Lunate | 2 | 5 | Implant |
