21 CFR 888.3170 — Prosthesis, Elbow, Hemi-, Radial, Polymer

Orthopedic (OR) · Part 888 Subpart D—Prosthetic Devices · § 888.3170

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.

Classification Rationale

Class II.

Product Codes

Product CodeDevice NameClassDevicesAttributes
KWIProsthesis, Elbow, Hemi-, Radial, Polymer233Implant
Innolitics

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