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510(k) Data Aggregation
Device Name
ARTHREX UNIVERS 30 SHOULDER PROSTHESISManufacturer
Date Cleared
2001-04-06
(80 days)
Product Code
Regulation Number
888.3660Type
TraditionalPanel
OrthopedicAge Range
N/A
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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