KIG · Prosthesis, Wrist, Constrained, Polymer
Orthopedic · 21 CFR 888.3780 · Class 2
Overview
| Product Code | KIG |
|---|---|
| Device Name | Prosthesis, Wrist, Constrained, Polymer |
| Regulation | 21 CFR 888.3780 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
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.
Cleared Devices (0)
No cleared devices on record.
