21 C.F.R. § 888.3230

Current through October 31, 2024
Section 888.3230 - Finger joint polymer constrained prosthesis
(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.

21 C.F.R. §888.3230