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§ 882.5900 Preformed craniosynostosis strip.

21 CFR 882.5900

Citation21 CFR 882.5900
CorpusDaily eCFR
Displayed edition2026-04-15
Last updated2026-04-15

§ 882.5900 Preformed craniosynostosis strip.

(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).