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K Number
K002523

Validate with FDA (Live)

Device Name
ADVANTAGE DRIVE SYSTEM
Manufacturer
LINVATEC CORP.
Date Cleared
2000-10-06

(52 days)

Product Code
HBC
Regulation Number
882.4360
Type
Traditional
Panel
Neurology
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
K012453,K012456,K012457,K022986,K050519,K061134,K081277,K081475,K092977,K161307
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 882.4360 Electric cranial drill motor.

(a)
Identification. An electric cranial drill motor is an electrically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull.(b)
Classification. Class II (performance standards).