CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 888—ORTHOPEDIC DEVICES > SUBPART D—Prosthetic Devices (§888.3000 to §888.3810) > 888.3020—Intramedullary fixation rod.

888.3020—Intramedullary fixation rod.

(a) Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.
(b) Classification. Class II.