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Code · CFR · Title 21 — Food and Drugs · Part 888 — Orthopedic Devices · § 888.3720

§ 888.3720. Toe joint polymer constrained prosthesis.

57 words·~1 min read·/us/cfr/t21/s§ 888.3720·

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

(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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