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510(k) Data Aggregation
K Number
K101837Device Name
ACL TIGHTROPE DOUBLE BUNDLEManufacturer
Date Cleared
2010-12-28
(180 days)
Regulation Number
888.3040Type
TraditionalPanel
OrthopedicReference & Predicate Devices
N/A
Why did this record match?
Device Name :
ACL TIGHTROPE DOUBLE BUNDLE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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