21 CFR 882.5900
§ 882.5900 Preformed craniosynostosis strip.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 882.5900, § 882.5900 Preformed craniosynostosis strip, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90764
- Permanent ID
ys:prov:90764@1- SHA-256
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Full text
(a) Identification. A preformed craniosynostosis strip is a plastic strip used to cover bone edges of craniectomy sites (sites where the skull has been cut) to prevent the bone from regrowing in patients whose skull sutures are abnormally fused together.
(b) Classification. Class II (performance standards).
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.