21 C.F.R. § 888.3780

Current through October 31, 2024
Section 888.3780 - Wrist joint polymer constrained prosthesis
(a)Identification. A wrist joint polymer constrained prosthesis is a device made of polyester-reinforced silicone elastomer intended to be implanted to replace a wrist 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.

21 C.F.R. §888.3780