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510(k) Data Aggregation
K Number
K010246Device Name
KYPHX INFLATABLE BONE TAMP, SIZE 20/3,MODEL K01A, KYPHX INFLATABLE BONE TAMP, SIZE 15/3, MODEL K02AManufacturer
Date Cleared
2001-02-14
(19 days)
Product Code
Regulation Number
888.1100Type
TraditionalPanel
Orthopedic (OR)Reference & Predicate Devices
N/A
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Device Name :
KYPHX INFLATABLE BONE TAMP, SIZE 20/3,MODEL K01A, KYPHX INFLATABLE BONE TAMP, SIZE 15/3, MODEL K02A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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