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K Number
K964402
Device Name
VERSATRAC (TM) LUMBAR RETRACTOR SYSTEM
Manufacturer
V. MUELLER NEURO/SPINE
Date Cleared
1997-01-23

(80 days)

Product Code
GZT
Regulation Number
882.4800
Type
Traditional
Panel
NE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 882.4800 Self-retaining retractor for neurosurgery.

(a)
Identification. A self-retaining retractor for neurosurgery is a self-locking device used to hold the edges of a wound open during neurosurgery.(b)
Classification. Class II (performance standards).