21 C.F.R. § 888.3730 Toe joint phalangeal (hemi-toe) polymer prosthesis.
Title 21 - Food and Drugs
(a) Identification. A toe joint phalangeal (hemi-toe) polymer prosthesis is a device made of silicone elastomer intended to be implanted to replace the base of the proximal phalanx of the toe. (b) Classification. Class II.
Title 21: Food and Drugs
PART 888—ORTHOPEDIC DEVICES
Subpart D—Prosthetic Devices
§ 888.3730 Toe joint phalangeal (hemi-toe) polymer prosthesis.