21 CFR § 882.5900 Neurological Devices

§ 882.5900 Preformed craniosynostosis strip.

Current through Sep 8, 2026 · Read all of Part 882

⚠ 2 pending changes to Part 882

(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).

← § 882.5899 Trunk and limb electrical stimulator to treat headache.§ 882.5910 Dura substitute. →