Code of Federal Regulations (alpha)

CFR /  Title 21  /  Part 888  /  Sec. 888.3730 Toe joint phalangeal (hemi-toe) polymer prosthesis.

(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.