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510(k) Data Aggregation

    K Number
    K254105

    Validate with FDA (Live)

    Device Name
    Hive™ Standalone Cervical System and Hive™ C Interbody System
    Manufacturer
    NanoHive Medical, LLC
    Date Cleared
    2026-02-13

    (56 days)

    Product Code
    ODP
    Regulation Number
    888.3080
    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
    K253381

    Validate with FDA (Live)

    Device Name
    Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application
    Manufacturer
    Medtronic Navigation, Inc.
    Date Cleared
    2026-02-12

    (135 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
    K253201

    Validate with FDA (Live)

    Device Name
    Lumbar Spine Truss System - Plating Solution (LSTS-PS)
    Manufacturer
    4Web, Inc.
    Date Cleared
    2026-02-12

    (139 days)

    Product Code
    KWQ
    Regulation Number
    888.3060
    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
    K251732

    Validate with FDA (Live)

    Device Name
    Wrist Fracture System
    Manufacturer
    Met One Technologies, LLC
    Date Cleared
    2026-02-12

    (251 days)

    Product Code
    N/A
    Regulation Number
    N/A
    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
    K253488

    Validate with FDA (Live)

    Device Name
    iFuse INTRA Ti™ Implant System
    Manufacturer
    SI-BONE, Inc.
    Date Cleared
    2026-02-11

    (110 days)

    Product Code
    OUR
    Regulation Number
    888.3040
    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
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    K Number
    K260073

    Validate with FDA (Live)

    Device Name
    XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm
    Manufacturer
    Biodynamik, Inc.
    Date Cleared
    2026-02-10

    (32 days)

    Product Code
    JDW
    Regulation Number
    888.3040
    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
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    K Number
    K253545

    Validate with FDA (Live)

    Device Name
    Vulcan Spinal System
    Manufacturer
    K2m,Inc.
    Date Cleared
    2026-02-10

    (88 days)

    Product Code
    NKB
    Regulation Number
    888.3070
    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
    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
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K252058

    Validate with FDA (Live)

    Device Name
    ROSA Knee System with UltraSound Imaging Platform (USIP)
    Manufacturer
    Balmoral Medical, LLC
    Date Cleared
    2026-02-06

    (220 days)

    Product Code
    OLO,ITX,IYO,KKX
    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
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K252873

    Validate with FDA (Live)

    Device Name
    Q Interbody Instruments
    Manufacturer
    K2m,Inc.
    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
    Intended Use
    Device Description
    AI/ML Overview
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