21 CFR 878.3250
§ 878.3250 External facial fracture fixation appliance.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 878.3250, § 878.3250 External facial fracture fixation appliance, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90386
- Permanent ID
ys:prov:90386@1- SHA-256
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Full text
(a) Identification. An external facial fracture fixation appliance is a metal apparatus intended to be used during surgical reconstruction and repair to immobilize maxillofacial bone fragments in their proper facial relationship.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.