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510(k) Data Aggregation

    K Number
    K253363

    Validate with FDA (Live)

    Device Name
    NeuroSpan Bridge
    Manufacturer
    Auxilium Biotechnologies, Inc.
    Date Cleared
    2026-01-17

    (109 days)

    Product Code
    JXI
    Regulation Number
    882.5275
    Type
    Traditional
    Panel
    Neurology
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K254126

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    Device Name
    Natrelle 133S Tissue Expanders
    Manufacturer
    AbbVie
    Date Cleared
    2026-01-16

    (28 days)

    Product Code
    LCJ
    Regulation Number
    N/A
    Type
    Special
    Panel
    General & Plastic Surgery
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252807

    Validate with FDA (Live)

    Device Name
    Arthrex Anatomic Lapidus Plates and I-Beam Lapidus Plates
    Manufacturer
    Arthrex, Inc.
    Date Cleared
    2026-01-12

    (131 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252842

    Validate with FDA (Live)

    Device Name
    SafeOp 3: Neural Informatix System
    Manufacturer
    Alphatec Spine, Inc.
    Date Cleared
    2026-01-11

    (125 days)

    Product Code
    GWF
    Regulation Number
    882.1870
    Type
    Traditional
    Panel
    Neurology
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252589

    Validate with FDA (Live)

    Device Name
    Corvair Monza
    Manufacturer
    AliveCor, Inc.
    Date Cleared
    2026-01-09

    (147 days)

    Product Code
    MHX
    Regulation Number
    870.1025
    Type
    Traditional
    Panel
    Cardiovascular
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252970

    Validate with FDA (Live)

    Device Name
    BriefCase-Triage: CARE Multi-triage CT Body
    Manufacturer
    Aidoc Medical , Ltd.
    Date Cleared
    2026-01-07

    (112 days)

    Product Code
    QAS
    Regulation Number
    892.2080
    Type
    Traditional
    Panel
    Radiology
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252507

    Validate with FDA (Live)

    Device Name
    SmileInspector
    Manufacturer
    Amv Consulting, LLC
    Date Cleared
    2026-01-07

    (152 days)

    Product Code
    PNN
    Regulation Number
    872.5470
    Type
    Traditional
    Panel
    Dental
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K251207

    Validate with FDA (Live)

    Device Name
    Sangria™ Thrombectomy System
    Manufacturer
    Avantec Vascular Corporation
    Date Cleared
    2026-01-07

    (264 days)

    Product Code
    QEW
    Regulation Number
    870.5150
    Type
    Traditional
    Panel
    Cardiovascular
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K253618

    Validate with FDA (Live)

    Device Name
    QuadLock™ Fixation System
    Manufacturer
    Abanza Tecnomed S.L
    Date Cleared
    2026-01-06

    (49 days)

    Product Code
    MBI
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K253854

    Validate with FDA (Live)

    Device Name
    MONTAGE XT Cranial Cement
    Manufacturer
    Abyrx, Inc.
    Date Cleared
    2026-01-02

    (30 days)

    Product Code
    GXP
    Regulation Number
    882.5300
    Type
    Special
    Panel
    Neurology
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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