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510(k) Data Aggregation

    K Number
    K252610

    Validate with FDA (Live)

    Device Name
    ZSFab Lumbar Interbody System
    Manufacturer
    Zsfab, Inc.
    Date Cleared
    2025-11-25

    (99 days)

    Product Code
    MAX
    Regulation Number
    888.3080
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K123456,K654321
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ZSFab Lumbar Interbody System is intended for lumbar interbody

    Device Description

    The ZSFab Lumbar Interbody System is intended for lumbar interbody

    AI/ML Overview

    N/A

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