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510(k) Data Aggregation
K Number
K010845Device Name
MODIFICATION TO OSTEONICS SPINAL SYSTEMManufacturer
Date Cleared
2001-04-18
(28 days)
Regulation Number
888.3070Type
SpecialPanel
Orthopedic (OR)Reference & Predicate Devices
N/A
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Device Name :
MODIFICATION TO OSTEONICS SPINAL SYSTEM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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