K Number
DEN210044Device Name
CERAMENT GManufacturer
Date Cleared
2022-05-17
(231 days)
Product Code
Regulation Number
888.3046Type
DirectPanel
ORReference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
N/A