Code of Federal Regulations · Section

§ 888.3720 — Toe Joint Polymer Constrained Prosthesis

21 C.F.R. § 888.3720

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(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.

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