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510(k) Data Aggregation
K Number
K003215Manufacturer
Date Cleared
2000-12-27
(75 days)
Product Code
Regulation Number
888.3030Type
TraditionalPanel
OrthopedicReference & Predicate Devices
N/A
Why did this record match?
Device Name :
MODIFICATION OF FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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