K Number
K010535Device Name
TRIFIX SPINAL FIXATION SYSTEMManufacturer
Date Cleared
2001-03-19
(24 days)
Regulation Number
888.3070Type
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