21 CFR § 882.5900 - Preformed craniosynostosis strip.

---
identifier: "/us/cfr/t21/s882.5900"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 882.5900 - Preformed craniosynostosis strip."
title_number: 21
title_name: "Food and Drugs"
section_number: "882.5900"
section_name: "Preformed craniosynostosis strip."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "882"
part_name: "NEUROLOGICAL DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "44 FR 51730, Sept. 4, 1979, unless otherwise noted."
cfr_part: "882"
---


# 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).