21 CFR 888.3180 — Prosthesis, Elbow, Hemi-, Humeral, Metal

Orthopedic (OR) · Part 888 Subpart D—Prosthetic Devices · § 888.3180

Identification

An elbow joint humeral (hemi-elbow) metallic uncemented prosthesis is a device intended to be implanted made of alloys, such as cobalt-chromium-molybdenum, that is used to replace the distal end of the humerus formed by the trochlea humeri and the capitulum humeri. The generic type of device is limited to prostheses intended for use without bone cement (§ 888.3027).

Classification Rationale

Class III.

Product Codes

Product CodeDevice NameClassDevicesAttributes
KWJProsthesis, Elbow, Hemi-, Humeral, Metal30Implant
Innolitics

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