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510(k) Data Aggregation

    K Number
    K253867

    Validate with FDA (Live)

    Device Name
    FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit
    Manufacturer
    ZuriMED Technologies AG
    Date Cleared
    2026-01-02

    (30 days)

    Product Code
    N/A
    Regulation Number
    N/A
    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
    K253854

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    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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    K Number
    K252817

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    Device Name
    Mobility Scooter (BC-MS310)
    Manufacturer
    Ningbo Baichen Medical Devices Co., Ltd.
    Date Cleared
    2026-01-02

    (120 days)

    Product Code
    INI
    Regulation Number
    890.3800
    Type
    Traditional
    Panel
    Physical Medicine
    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
    K251178

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    Device Name
    Ready to use Nelaton Catheter
    Manufacturer
    Jamjoom Fullcare Corporation
    Date Cleared
    2026-01-02

    (261 days)

    Product Code
    EZD
    Regulation Number
    876.5130
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    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
    K243627

    Validate with FDA (Live)

    Device Name
    Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC)
    Manufacturer
    Arc Trauma, LLC
    Date Cleared
    2025-12-31

    (401 days)

    Product Code
    DXC
    Regulation Number
    870.4450
    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
    K253888

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    Device Name
    MOLLI 2 System
    Manufacturer
    Stryker Endoscopy
    Date Cleared
    2025-12-31

    (27 days)

    Product Code
    NEU
    Regulation Number
    878.4300
    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
    K252901

    Validate with FDA (Live)

    Device Name
    Tyber Medical Trauma Screw
    Manufacturer
    Tyber Medical, LLC
    Date Cleared
    2025-12-31

    (111 days)

    Product Code
    N/A
    Regulation Number
    N/A
    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
    K252951

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    Device Name
    Genesis Sleep
    Manufacturer
    Neurofield, Inc.
    Date Cleared
    2025-12-31

    (106 days)

    Product Code
    QJQ
    Regulation Number
    882.5800
    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
    K253305

    Validate with FDA (Live)

    Device Name
    TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)
    Manufacturer
    Shenzhen Jiantuo Electronics Co., Ltd.
    Date Cleared
    2025-12-31

    (93 days)

    Product Code
    NUH
    Regulation Number
    882.5890
    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
    K253532

    Validate with FDA (Live)

    Device Name
    TruSPECT Processing Station
    Manufacturer
    Spectrum Dynamics Medical, Ltd.
    Date Cleared
    2025-12-30

    (47 days)

    Product Code
    QIH
    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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