Code of Federal Regulations · Section
§ 882.5360 — Cranioplasty Plate Fastener
21 C.F.R. § 882.5360
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(a) Identification. A cranioplasty plate fastener is a screw, wire, or other article made of tantalum, vitallium, or stainless steel used to secure a plate to the patient's skull to repair a skull defect.
(b) Classification. Class II (performance standards).
Authorizing Statute
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Adulterated drugs and devices21 U.S.C. § 351