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Code · CFR · Title 21 — Food and Drugs · Part 882 — Neurological Devices · § 882.5320

§ 882.5320. Preformed alterable cranioplasty plate.

54 words·~1 min read·/us/cfr/t21/s§ 882.5320·

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(a)Identification. A preformed alterable cranioplasty plate is a device that is implanted into a patient to repair a skull defect. It is constructed of a material, e.g., tantalum, that can be altered or reshaped at the time of surgery without changing the chemical behavior of the material.
(b)Classification. Class II (performance standards).
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§ 882.5320
Preformed alterable cranioplasty plate.
Fed. Reg.×1
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