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510(k) Data Aggregation
K Number
K082032Device Name
SEQUOIA SPINAL SYSTEM (MODEL 3306), SPEEDLINK TRANSVERSE CONNECTOR (MODELS 3308, 3309, 3310)Manufacturer
Date Cleared
2008-10-06
(81 days)
Product Code
Regulation Number
888.3070Type
TraditionalPanel
OrthopedicReference & Predicate Devices
N/A
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Device Name :
SEQUOIA SPINAL SYSTEM (MODEL 3306), SPEEDLINK TRANSVERSE CONNECTOR (MODELS 3308, 3309, 3310)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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