Code of Federal Regulations · Section
§ 888.3720 — Toe Joint Polymer Constrained Prosthesis
21 C.F.R. § 888.3720
View:
(a) Identification. A toe joint polymer constrained prosthesis is a device made of silicone elastomer or polyester reinforced silicone elastomer intended to be implanted to replace the first metatarsophalangeal (big toe) joint. This generic type of device consists of a single flexible across-the-joint component that prevents dislocation in more than one anatomic plane.
(b) Classification. Class II.
Authorizing Statute
-
Adulterated drugs and devices21 U.S.C. § 351