21 Food and Drugs 8 2003-04-01 2003-04-01 false Wrist joint carpal scaphoid polymer prosthesis. 888.3760 Section 888.3760 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices
ยง 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.