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510(k) Data Aggregation
K Number
K241906Device Name
BioBrace® Reinforced ImplantManufacturer
Date Cleared
2024-07-29
(28 days)
Product Code
Regulation Number
878.3300Type
SpecialPanel
Orthopedic (OR)Reference & Predicate Devices
N/A
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Device Name :
BioBrace**®** Reinforced Implant
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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