21 CFR 888.3770 — Prosthesis, Wrist, Carpal Trapezium

Orthopedic (OR) · Part 888 Subpart D—Prosthetic Devices · § 888.3770

Identification

A wrist joint carpal trapezium polymer prosthesis is a one-piece device made of silicone elastomer or silicone elastomer/polyester material intended to be implanted to replace the carpal trapezium bone of the wrist.

Classification Rationale

Class II.

Product Codes

Product CodeDevice NameClassDevicesAttributes
KYIProsthesis, Wrist, Carpal Trapezium226Implant
Innolitics

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