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510(k) Data Aggregation
K Number
K010437Device Name
MODIFICATION TO EBI XFIX DFS RAIL SYSTEMManufacturer
Date Cleared
2001-03-13
(28 days)
Product Code
Regulation Number
888.3030Type
SpecialPanel
OrthopedicReference & Predicate Devices
N/A
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Device Name :
MODIFICATION TO EBI XFIX DFS RAIL SYSTEM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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