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510(k) Data Aggregation

    K Number
    K252871

    Validate with FDA (Live)

    Device Name
    Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories
    Manufacturer
    Stryker Leibinger GmbH & Co KG
    Date Cleared
    2026-02-06

    (149 days)

    Product Code
    OLO
    Regulation Number
    882.4560
    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
    K251614

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    Device Name
    Stainless Steel Surgical Kits
    Manufacturer
    Dentsply Sirona, Inc.
    Date Cleared
    2026-02-06

    (255 days)

    Product Code
    KCT
    Regulation Number
    880.6850
    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
    K251577

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    Device Name
    LAIA XR
    Manufacturer
    Augmented Reality Software S.L.
    Date Cleared
    2026-02-06

    (260 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    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
    K251836

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    Device Name
    Dermatrix Duo
    Manufacturer
    Shenzhen Gsd Technology Co., Ltd.
    Date Cleared
    2026-02-06

    (235 days)

    Product Code
    GEI
    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
    K251474

    Validate with FDA (Live)

    Device Name
    Median LCS (internal name) / eyonis LCS (trade name) (1.0)
    Manufacturer
    Median Technologies
    Date Cleared
    2026-02-06

    (269 days)

    Product Code
    QDQ
    Regulation Number
    892.2090
    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
    K243348

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    Device Name
    Athelas Home
    Manufacturer
    Athelas, Inc.
    Date Cleared
    2026-02-06

    (466 days)

    Product Code
    GKZ
    Regulation Number
    864.5220
    Type
    Traditional
    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
    K253221

    Validate with FDA (Live)

    Device Name
    Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)
    Manufacturer
    Eieling Technology (Shenzhen) Limited
    Date Cleared
    2026-02-06

    (130 days)

    Product Code
    IYO
    Regulation Number
    892.1560
    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
    DEN250006

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    Device Name
    Amferia Wound Dressing
    Manufacturer
    Amferia AB
    Date Cleared
    2026-02-06

    (340 days)

    Product Code
    SHA
    Regulation Number
    N/A
    Type
    Direct
    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
    K243979

    Validate with FDA (Live)

    Device Name
    Aptiva APS IgA Reagent
    Manufacturer
    Inova Diagnostics, Inc.
    Date Cleared
    2026-02-06

    (410 days)

    Product Code
    MSV
    Regulation Number
    866.5660
    Type
    Traditional
    Panel
    Immunology
    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
    K251507

    Validate with FDA (Live)

    Device Name
    INTEGRE LIO
    Manufacturer
    Quantel Medical
    Date Cleared
    2026-02-06

    (266 days)

    Product Code
    HQF
    Regulation Number
    886.4390
    Type
    Traditional
    Panel
    Ophthalmic
    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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