21 CFR 888.3790 — Prosthesis, Wrist, Constrained, Metal

Orthopedic (OR) · Part 888 Subpart D—Prosthetic Devices · § 888.3790

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.

Product Codes

Product CodeDevice NameClassDevicesAttributes
KYNProsthesis, Wrist, Constrained, Metal30Implant
Innolitics

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