21 CFR 882.5250 — Cover, Burr Hole

Neurology (NE) · Part 882 Subpart F—Neurological Therapeutic Devices · § 882.5250

Identification

A burr hole cover is a plastic or metal device used to cover or plug holes drilled into the skull during surgery and to reattach cranial bone removed during surgery.

Classification Rationale

Class II (performance standards).

Product Codes

Product CodeDevice NameClassDevicesAttributes
GXRCover, Burr Hole229Implant
Innolitics

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