KYN · Prosthesis, Wrist, Constrained, Metal
Orthopedic · 21 CFR 888.3790 · Class 3
Overview
| Product Code | KYN |
|---|---|
| Device Name | Prosthesis, Wrist, Constrained, Metal |
| Regulation | 21 CFR 888.3790 |
| Device Class | Class 3 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
A wrist joint metal constrained cemented prosthesis is a device intended to be implanted to replace a wrist joint. The device prevents dislocation in more than one anatomic plane and consists of either a single flexible across-the-joint component or two components linked together. This generic type of device is limited to a device which is made of alloys, such as cobalt-chromium-molybdenum, and is limited to those prostheses intended for use with bone cement (§ 888.3027).
Classification Rationale
Class III.
Cleared Devices (0)
No cleared devices on record.
