KWF · Prosthesis, Finger, Polymer
Orthopedic · 21 CFR 888.3230 · Class 2
Overview
| Product Code | KWF |
|---|---|
| Device Name | Prosthesis, Finger, Polymer |
| Regulation | 21 CFR 888.3230 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
A finger joint polymer constrained prosthesis is a device intended to be implanted to replace a metacarpophalangeal or proximal interphalangeal (finger) joint. This generic type of device includes prostheses that consist of a single flexible across-the-joint component made from either a silicone elastomer or a combination pf polypropylene and polyester material. The flexible across-the-joint component may be covered with a silicone rubber sleeve.
Classification Rationale
Class II.
Cleared Devices (0)
No cleared devices on record.
