K Number
K003428Device Name
ISS OFFSET HEADSManufacturer
Date Cleared
2000-11-24
(21 days)
Product Code
Regulation Number
888.3690Type
SpecialPanel
OrthopedicReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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N/A