1. LawStack
  2. Title 21 - Food and Drugs
  3. Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  4. Subchapter H - MEDICAL DEVICES
  5. Part 888 - ORTHOPEDIC DEVICES
  6. Subpart D - Prosthetic Devices
  7. 21 CFR § 888.3170
21 CFR § 888.3170
Elbow joint radial (hemi-elbow) polymer prosthesis
June 25, 2020
CFR

(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.

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

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