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510(k) Data Aggregation

    K Number
    K260561

    Validate with FDA (Live)

    Device Name
    Arthrex FiberTak Suture Anchor
    Manufacturer
    Arthrex, Inc.
    Date Cleared
    2026-03-20

    (29 days)

    Product Code
    MBI
    Regulation Number
    888.3040
    Type
    Special
    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
    K252016

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    Device Name
    Arthrex Humeral Nails
    Manufacturer
    Arthrex, Inc.
    Date Cleared
    2026-03-20

    (266 days)

    Product Code
    HSB
    Regulation Number
    888.3020
    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
    K260509

    Validate with FDA (Live)

    Device Name
    AutoContour (RADAC V5)
    Manufacturer
    Radformation, Inc.
    Date Cleared
    2026-03-19

    (30 days)

    Product Code
    QKB
    Regulation Number
    892.2050
    Type
    Special
    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
    K253012

    Validate with FDA (Live)

    Device Name
    AlignRT Plus (8.0)
    Manufacturer
    Vision Rt, Ltd.
    Date Cleared
    2026-03-18

    (180 days)

    Product Code
    IYE
    Regulation Number
    892.5050
    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
    K260830

    Validate with FDA (Live)

    Device Name
    APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste)
    Manufacturer
    Sangi Co., Ltd.
    Date Cleared
    2026-03-18

    (5 days)

    Product Code
    LBH
    Regulation Number
    872.3260
    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
    K254053

    Validate with FDA (Live)

    Device Name
    APS Spear Locking Plate
    Manufacturer
    A Plus Biotechnology Co., Ltd.
    Date Cleared
    2026-03-17

    (90 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
    K253916

    Validate with FDA (Live)

    Device Name
    APTUS Shoulder Proximal Humerus System, PentaLock 3.5
    Manufacturer
    Medartis AG
    Date Cleared
    2026-03-16

    (98 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
    K253261

    Validate with FDA (Live)

    Device Name
    Apollo Quattro (APQ-10M)
    Manufacturer
    Weero Co., Ltd.
    Date Cleared
    2026-03-13

    (165 days)

    Product Code
    PBX
    Regulation Number
    878.4400
    Type
    Traditional
    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
    K254059

    Validate with FDA (Live)

    Device Name
    Access anti-HBc IgM
    Manufacturer
    Beckman Coulter, Inc.
    Date Cleared
    2026-03-13

    (86 days)

    Product Code
    SEI
    Regulation Number
    866.3173
    Type
    Traditional
    Panel
    Microbiology
    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
    K260499

    Validate with FDA (Live)

    Device Name
    Amplatzer™ Trevisio™ Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80
    Manufacturer
    Abbott Medical
    Date Cleared
    2026-03-13

    (28 days)

    Product Code
    DQY
    Regulation Number
    870.1250
    Type
    Special
    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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