21 CFR 888.3780 — Prosthesis, Wrist, Constrained, Polymer
Orthopedic (OR) · Part 888 Subpart D—Prosthetic Devices · § 888.3780
Identification
A wrist joint polymer constrained prosthesis is a device made of polyester-reinforced silicone elastomer intended to be implanted to replace a wrist joint. This generic type of device consists of a single flexible across-the-joint component that prevents dislocation in more than one anatomic plane.
Classification Rationale
Class II.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| KIG | Prosthesis, Wrist, Constrained, Polymer | 2 | 0 | Implant |
