Finger joint polymer constrained prosthesis.

21 C.F.R. § 888.3230
in effectEffective: 2024-07-01
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(a) Identification. A finger joint polymer constrained prosthesis is a device intended to be implanted to replace a metacarpophalangeal or proximal interphalangeal (finger) joint. This generic type of device includes prostheses that consist of a single flexible across-the-joint component made from either a silicone elastomer or a combination pf polypropylene and polyester material. The flexible across-the-joint component may be covered with a silicone rubber sleeve. (b) Classification. Class II.

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