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510(k) Data Aggregation

    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
    K254003

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    Device Name
    JARVIS Metaphyseal Stem
    Manufacturer
    FH Industrie
    Date Cleared
    2026-01-09

    (25 days)

    Product Code
    PHX,HSD,KWS
    Regulation Number
    888.3660
    Type
    Special
    Panel
    Orthopedic
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
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    K Number
    K252589

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    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
    K253957

    Validate with FDA (Live)

    Device Name
    HemosIL Silica Clotting Time
    Manufacturer
    Instrumentation Laboratory (IL) Co.
    Date Cleared
    2026-01-09

    (30 days)

    Product Code
    GFO
    Regulation Number
    864.7925
    Type
    Special
    Panel
    Hematology
    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
    K253075

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    Device Name
    Mobility scooter (Air Classic); Mobility scooter (Air Traveller); Mobility scooter (Air Traveller2.0)
    Manufacturer
    Suzhou Sweetrich Vehicle Industry Technology Co., Ltd.
    Date Cleared
    2026-01-09

    (108 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
    K252906

    Validate with FDA (Live)

    Device Name
    ECHELON ENDOPATH Staple Line Reinforcement (ECH60R)
    Manufacturer
    Ethicon Endo-Surgery, LLC
    Date Cleared
    2026-01-09

    (119 days)

    Product Code
    OXC
    Regulation Number
    878.3300
    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
    K253964

    Validate with FDA (Live)

    Device Name
    Disposable Neonatal NIBP Cuff (U1681S-C51N)
    Manufacturer
    Unimed Medical Supplies, Inc.
    Date Cleared
    2026-01-09

    (29 days)

    Product Code
    DXQ
    Regulation Number
    870.1120
    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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    K Number
    K251139

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    Device Name
    KabiHelp® Uno; KabiHelp® Advance plus
    Manufacturer
    Fresenius Kabi AG
    Date Cleared
    2026-01-09

    (270 days)

    Product Code
    KPE
    Regulation Number
    880.5025
    Type
    Traditional
    Panel
    General Hospital
    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
    K252674

    Validate with FDA (Live)

    Device Name
    Solo Pace Fusion System (SOLOFUSE1)
    Manufacturer
    Solo Pace, Inc.
    Date Cleared
    2026-01-09

    (137 days)

    Product Code
    DQX
    Regulation Number
    870.1330
    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
    K252206

    Validate with FDA (Live)

    Device Name
    Nova Allegro UACR Assay, Nova Allegro Analyzer
    Manufacturer
    Nova Biomedical Corporation
    Date Cleared
    2026-01-09

    (179 days)

    Product Code
    CGX
    Regulation Number
    862.1225
    Type
    Dual Track
    Panel
    Clinical Chemistry
    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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