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K Number
K002334

Validate with FDA (Live)

Device Name
MACROPORENS CRANILOC
Manufacturer
MACROPORE BIOSURGERY, INC.
Date Cleared
2001-05-02

(274 days)

Product Code
GXR
Regulation Number
882.5250
Type
Traditional
Panel
Neurology
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
K022277,K040080
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 882.5250 Burr hole cover.

(a)
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.(b)
Classification. Class II (performance standards).