21 CFR 882.5900 — Strip, Craniosynostosis, Preformed
Neurology (NE) · Part 882 Subpart F—Neurological Therapeutic Devices · § 882.5900
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.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GXO | Strip, Craniosynostosis, Preformed | 2 | 2 | Implant |
