Code of Federal Regulations · Section

§ 888.3750 — Wrist Joint Carpal Lunate Polymer Prosthesis

21 C.F.R. § 888.3750

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(a) Identification. A wrist joint carpal lunate prosthesis is a one-piece device made of silicone elastomer intended to be implanted to replace the carpal lunate bone of the wrist.

(b) Classification. Class II.

Authorizing Statute