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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
    K253221

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    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

    Validate with FDA (Live)

    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

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    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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    K Number
    K253780

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    Device Name
    SIGNA™ Bolt
    Manufacturer
    Ge Medical Systems, LLC
    Date Cleared
    2026-02-06

    (72 days)

    Product Code
    LNH,LNI,MOS
    Regulation Number
    892.1000
    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
    K251218

    Validate with FDA (Live)

    Device Name
    SafeBeat Rx App
    Manufacturer
    Safebeat Rx, Inc.
    Date Cleared
    2026-02-06

    (291 days)

    Product Code
    DQK
    Regulation Number
    870.1425
    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
    K253959

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    Device Name
    Primevision 3D
    Manufacturer
    Dentsply Sirona
    Date Cleared
    2026-02-05

    (57 days)

    Product Code
    OAS
    Regulation Number
    892.1750
    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
    K260038

    Validate with FDA (Live)

    Device Name
    E3D™-C Interbody System
    Manufacturer
    Evolution Spine
    Date Cleared
    2026-02-04

    (29 days)

    Product Code
    OVE
    Regulation Number
    888.3080
    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
    K252623

    Validate with FDA (Live)

    Device Name
    G7® Revision Acetabular System
    Manufacturer
    Zimmer, Inc.
    Date Cleared
    2026-02-04

    (169 days)

    Product Code
    LPH,KWZ,LZO,OQG,OQH,OQI,PBI
    Regulation Number
    888.3358
    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
    Intended Use
    Device Description
    AI/ML Overview
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