Device Name
A8 INTEGR8 Porous Pedicle ScrewsManufacturer
Date Cleared
2025-10-20
(397 days)
Product Code
Regulation Number
888.3070Type
TraditionalPanel
OrthopedicAge Range
N/A
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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N/A