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510(k) Data Aggregation

    K Number
    K260291

    Validate with FDA (Live)

    Device Name
    Vortex5 Tailor's Bunion Correction System
    Manufacturer
    Nvision Biomedical Technologies, Inc.
    Date Cleared
    2026-03-25

    (55 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    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
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    K Number
    K260274

    Validate with FDA (Live)

    Device Name
    Airlock® Ankle Plating System
    Manufacturer
    Novastep SAS
    Date Cleared
    2026-03-25

    (55 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Type
    Abbreviated
    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
    K254253

    Validate with FDA (Live)

    Device Name
    LOQTEQ® VA Proximal Humerus Plate 3.5
    Manufacturer
    Aap Implantate AG
    Date Cleared
    2026-03-24

    (85 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    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
    K254288

    Validate with FDA (Live)

    Device Name
    Clavicle Fixation System
    Manufacturer
    Skeletal Dynamics, Inc.
    Date Cleared
    2026-03-23

    (82 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Type
    Abbreviated
    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
    K260448

    Validate with FDA (Live)

    Device Name
    CastleLoc Pectus Bar System
    Manufacturer
    L&K BIOMED Co., Ltd.
    Date Cleared
    2026-03-19

    (36 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    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
    K254053

    Validate with FDA (Live)

    Device Name
    APS Spear Locking Plate
    Manufacturer
    A Plus Biotechnology Co., Ltd.
    Date Cleared
    2026-03-17

    (90 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    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
    K253916

    Validate with FDA (Live)

    Device Name
    APTUS Shoulder Proximal Humerus System, PentaLock 3.5
    Manufacturer
    Medartis AG
    Date Cleared
    2026-03-16

    (98 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    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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    Device Description
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    K Number
    K253906

    Validate with FDA (Live)

    Device Name
    Xpert Hand
    Manufacturer
    Newclip Technics
    Date Cleared
    2026-03-11

    (96 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    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
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    K Number
    K260069

    Validate with FDA (Live)

    Device Name
    DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating System
    Manufacturer
    Synthes GmbH
    Date Cleared
    2026-03-09

    (59 days)

    Product Code
    HRS,HTD,HWC,HWT
    Regulation Number
    888.3030
    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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    K Number
    K260353

    Validate with FDA (Live)

    Device Name
    Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button
    Manufacturer
    Arthrex, Inc.
    Date Cleared
    2026-03-03

    (28 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    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
    Intended Use
    Device Description
    AI/ML Overview
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