21 CFR 888.3210 — Prosthesis, Finger, Constrained, Metal, Cemented
Orthopedic (OR) · Part 888 Subpart D—Prosthetic Devices · § 888.3210
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| LBC | Prosthesis, Finger, Constrained, Metal, Cemented | 3 | 0 | Implant |