GroundRules
21 CFR 888.3170: Elbow joint radial (hemi-elbow) polymer prosthesis.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER H—MEDICAL DEVICES
- PART 888—ORTHOPEDIC DEVICES
- Subpart D—Prosthetic Devices
(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.
Collected 2026-08-27T02:24:47Z. Source file · JSON