21 CFR § 888.3730
Toe joint phalangeal (hemi-toe) polymer prosthesis
June 25, 2020
(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.