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K Number
K000536

Validate with FDA (Live)

Device Name
SYNTHES ANTERIOR CSLP SYSTEM
Manufacturer
SYNTHES SPINE
Date Cleared
2000-03-15

(28 days)

Product Code
KWQ
Regulation Number
888.3060
Type
Special
Panel
Orthopedic
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
K041989,K043066,K061147,K062310,K063430,K070681,K071990,K083020,K083338,K083562,K092474,K100215,K100265,K101682,K103070,K103137,K111132,K111135,K111370,K112861,K131025,K131810,K132994,K133245,K141253,K142237,K150184,K150983,K151553,K153446,K160522,K160702,K170342,K181139,K181190,K181471,K192494
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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