21 CFR 888.3760 - Wrist joint carpal scaphoid polymer prosthesis.

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Title 21: Food and Drugs

CHAPTER I: FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)

SUBCHAPTER H: MEDICAL DEVICES

PART 888: ORTHOPEDIC DEVICES

Subpart D: Prosthetic Devices

888.3760 - Wrist joint carpal scaphoid polymer prosthesis.

(a) Identification. A wrist joint carpal scaphoid polymer prosthesis is a one-piece device made of silicone elastomer intended to be implanted to replace the carpal scaphoid bone of the wrist.

(b) Classification. Class II.

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