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510(k) Data Aggregation

    K Number
    K253613

    Validate with FDA (Live)

    Device Name
    Monkey Rings External Ring Fixation System
    Manufacturer
    Paragon 28, Inc.
    Date Cleared
    2025-12-19

    (31 days)

    Product Code
    KTT
    Regulation Number
    888.3030
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K253202

    Validate with FDA (Live)

    Device Name
    Hoffmann LRF System
    Manufacturer
    Stryker GmbH
    Date Cleared
    2025-12-19

    (84 days)

    Product Code
    KTT
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K251050

    Validate with FDA (Live)

    Device Name
    Pectus Versa System
    Manufacturer
    Gm Dos Reis Industria E Comercio
    Date Cleared
    2025-12-19

    (260 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K253161

    Validate with FDA (Live)

    Device Name
    Balanced Knee System TriMax Porous Femoral Components
    Manufacturer
    Ortho Development Corp.
    Date Cleared
    2025-12-19

    (84 days)

    Product Code
    MBH
    Regulation Number
    888.3565
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
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    K Number
    K252781

    Validate with FDA (Live)

    Device Name
    MSFX MIKRON PEEK CAGES
    Manufacturer
    Mikron Makina Sanayi VE Tic. Ltd. Sti.
    Date Cleared
    2025-12-19

    (108 days)

    Product Code
    ODP
    Regulation Number
    888.3080
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
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    K Number
    K252974

    Validate with FDA (Live)

    Device Name
    EMPOWR Knee
    Manufacturer
    Encore Medical, LP
    Date Cleared
    2025-12-19

    (93 days)

    Product Code
    JWH,MBH,OIY
    Regulation Number
    888.3560
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
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    K Number
    K253577

    Validate with FDA (Live)

    Device Name
    IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)
    Manufacturer
    Medicrea International S.A.S. (Medtronic)
    Date Cleared
    2025-12-19

    (32 days)

    Product Code
    MAX
    Regulation Number
    888.3080
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
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    K Number
    K253093

    Validate with FDA (Live)

    Device Name
    Vital™ Spinal Fixation System
    Manufacturer
    Highridge Medical, LLC
    Date Cleared
    2025-12-17

    (85 days)

    Product Code
    NKB,KWP,KWQ
    Regulation Number
    888.3070
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K252191

    Validate with FDA (Live)

    Device Name
    BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus System
    Manufacturer
    Bonebridge AG
    Date Cleared
    2025-12-17

    (156 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K253721

    Validate with FDA (Live)

    Device Name
    KHEIRON® Spinal Fixation System, including patient specific K-ROD
    Manufacturer
    S.M.A.I.O
    Date Cleared
    2025-12-17

    (23 days)

    Product Code
    NKB
    Regulation Number
    888.3070
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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