LBC · Prosthesis, Finger, Constrained, Metal, Cemented
Orthopedic · 21 CFR 888.3210 · Class 3
Overview
| Product Code | LBC |
|---|---|
| Device Name | Prosthesis, Finger, Constrained, Metal, Cemented |
| Regulation | 21 CFR 888.3210 |
| Device Class | Class 3 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
A finger joint metal/metal constrained cemented prosthesis is a device intended to be implanted to replace a metacarpophalangeal (finger) joint. This device prevents dislocation in more than one anatomic plane and has components which are linked together. This generic type of device includes prostheses that are 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.
