21 CFR § 888.3170 Orthopedic Devices

§ 888.3170 Elbow joint radial (hemi-elbow) polymer prosthesis.

Current through Sep 8, 2026 · Read all of Part 888

(a) Identification. An elbow joint radial (hemi-elbow) polymer prosthesis is a device intended to be implanted made of medical grade silicone elastomer used to replace the proximal end of the radius.

(b) Classification. Class II.

← § 888.3160 Elbow joint metal/polymer semi-constrained cemented prosthesis.§ 888.3180 Elbow joint humeral (hemi-elbow) metallic uncemented prosthesis. →