Title 21: Food and Drugs
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/ PART 888 - ORTHOPEDIC DEVICES
/ Subpart D - Prosthetic Devices / § 888.3810 Wrist joint ulnar (hemi-wrist) polymer prosthesis.
§ 888.3810 Wrist joint ulnar (hemi-wrist) polymer prosthesis.
(a) Identification. A wrist joint ulnar (hemi-wrist) polymer prosthesis is a mushroom-shaped device made of a medical grade silicone elastomer or ultra-high molecular weight polyethylene intended to be implanted into the intramedullary canal of the bone and held in place by a suture. Its purpose is to cover the resected end of the distal ulna to control bone overgrowth and to provide an articular surface for the radius and carpus.
(b) Classification. Class II.