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510(k) Data Aggregation
K Number
K010434Device Name
OPTETRAK B-SERIES TOTAL KNEE SYSTEMManufacturer
Date Cleared
2001-03-13
(28 days)
Product Code
Regulation Number
888.3560Type
SpecialPanel
OrthopedicReference & Predicate Devices
N/A
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Device Name :
OPTETRAK B-SERIES TOTAL KNEE SYSTEM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
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