21 CFR 888.3040
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 888.3040, § 888.3040 Smooth or threaded metallic bone fixation fastener, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/91061
- Permanent ID
ys:prov:91061@1- SHA-256
17e066c9632be8ae80400be86b5dbef1376645e26133cd5c74e9c750203babc1
The hash is SHA-256 of this version's text, with every run of whitespace collapsed to a single space and the ends trimmed. The ID always leads back here, and checking it says whether the text you cited is still the current version.
Full text
(a) Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.
(b) Classification. Class II.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.