Code of Federal Regulations · Section
§ 888.3730 — Toe Joint Phalangeal (hemi-toe) Polymer Prosthesis
21 C.F.R. § 888.3730
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(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.
Authorizing Statute
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Adulterated drugs and devices21 U.S.C. § 351