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21 C.F.R. § 888.3770   Wrist joint carpal trapezium polymer prosthesis.

Title 21 - Food and Drugs

Title 21: Food and Drugs
PART 888—ORTHOPEDIC DEVICES
Subpart D—Prosthetic Devices

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§ 888.3770   Wrist joint carpal trapezium polymer prosthesis.

(a) 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.

(b) Classification. Class II.

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