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    K Number
    K252562
    Device Name
    Spine & Trauma Navigation Instruments
    Manufacturer
    Brainlab AG
    Date Cleared
    2025-09-12

    (29 days)

    Product Code
    OLO
    Regulation Number
    882.4560
    Type
    Special
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Panel :

    Orthopedic (OR)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K250628
    Device Name
    DynaNail TTC Fusion System
    Manufacturer
    MedShape, Inc.
    Date Cleared
    2025-09-12

    (193 days)

    Product Code
    HSB
    Regulation Number
    888.3020
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Panel :

    Orthopedic (OR)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K251316
    Device Name
    Mazor X System / Mazor X Stealth Edition
    Manufacturer
    Mazor Robotics Ltd.
    Date Cleared
    2025-09-11

    (135 days)

    Product Code
    OLO
    Regulation Number
    882.4560
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Panel :

    Orthopedic (OR)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
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    K Number
    K250216
    Device Name
    OsteoProbe (OP-100)
    Manufacturer
    Active Life Scientific, Inc.
    Date Cleared
    2025-09-11

    (230 days)

    Product Code
    QGQ
    Regulation Number
    888.1600
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Panel :

    Orthopedic (OR)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
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    K Number
    K252530
    Device Name
    OptiVu™ Shoulder
    Manufacturer
    MR Surgical Solutions, LLC
    Date Cleared
    2025-09-10

    (30 days)

    Product Code
    SBF
    Regulation Number
    882.4560
    Type
    Special
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Panel :

    Orthopedic (OR)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K252524
    Device Name
    Quadsense (Quadsense and Quadsense Pro)
    Manufacturer
    Eventum Orthopaedics Ltd
    Date Cleared
    2025-09-09

    (29 days)

    Product Code
    ONN
    Regulation Number
    882.4560
    Type
    Special
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Panel :

    Orthopedic (OR)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K251892
    Device Name
    MAXXOS P.A.C.E. Foot & Ankle Plating System
    Manufacturer
    MAXXOS Medical GmbH
    Date Cleared
    2025-09-08

    (80 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Panel :

    Orthopedic (OR)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
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    K Number
    K250095
    Device Name
    All-Suture Dual Anchor System
    Manufacturer
    SutureTech, Inc.
    Date Cleared
    2025-09-05

    (234 days)

    Product Code
    MBI
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Panel :

    Orthopedic (OR)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
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    K Number
    K251444
    Device Name
    Endoskeleton™ Interbody Systems
    Manufacturer
    Medtronic Sofamor Danek USA, Inc.
    Date Cleared
    2025-09-04

    (118 days)

    Product Code
    MAX,ODP,OVD,OVE
    Regulation Number
    888.3080
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Panel :

    Orthopedic (OR)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K251737
    Device Name
    NextAR(TM) Shoulder Platform
    Manufacturer
    Medacta International S.A.
    Date Cleared
    2025-09-04

    (90 days)

    Product Code
    SBF
    Regulation Number
    882.4560
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Panel :

    Orthopedic (OR)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

    Ask a specific question about this device

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