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510(k) Data Aggregation

    K Number
    K253674

    Validate with FDA (Live)

    Device Name
    Blueprint Patient-Specific Instrumentation
    Manufacturer
    Stryker Corporation (Tornier, S.A.S.)
    Date Cleared
    2026-04-03

    (133 days)

    Product Code
    PHX
    Regulation Number
    888.3660
    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
    K250074

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    Device Name
    HYALEX® MTP Hemiarthroplasty Implant
    Manufacturer
    Hyalex Orthopaedics, Inc.
    Date Cleared
    2026-04-03

    (448 days)

    Product Code
    KWD
    Regulation Number
    888.3730
    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
    K253042

    Validate with FDA (Live)

    Device Name
    Tyber Medical Trauma Screw
    Manufacturer
    Tyber Medical, LLC
    Date Cleared
    2026-04-03

    (193 days)

    Product Code
    HWC
    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
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    K Number
    K260786

    Validate with FDA (Live)

    Device Name
    KHEIRON® Spinal Fixation System, including patient specific K-ROD
    Manufacturer
    S.M.A.I.O
    Date Cleared
    2026-04-03

    (24 days)

    Product Code
    NKB
    Regulation Number
    888.3070
    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
    K260796

    Validate with FDA (Live)

    Device Name
    Tahoe Unicondylar Knee System with TiNbN Overcoat
    Manufacturer
    Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics
    Date Cleared
    2026-04-02

    (22 days)

    Product Code
    HSX
    Regulation Number
    888.3520
    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
    K242303

    Validate with FDA (Live)

    Device Name
    MOD-C
    Manufacturer
    Orthomod, LLC
    Date Cleared
    2026-04-01

    (604 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
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    K Number
    K253718

    Validate with FDA (Live)

    Device Name
    enHAnce PEEK Bunion System
    Manufacturer
    Nvision Biomedical Technologies, Inc.
    Date Cleared
    2026-04-01

    (128 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
    K260037

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    Device Name
    implantcast Packaging System Update
    Manufacturer
    Implantcast GmbH
    Date Cleared
    2026-03-30

    (83 days)

    Product Code
    LZO,HSD,HSX,JDI,JWH,KWT,KWY,MEH,OQI,PHX
    Regulation Number
    888.3353
    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
    K252240

    Validate with FDA (Live)

    Device Name
    Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System
    Manufacturer
    Spectrum Spine
    Date Cleared
    2026-03-30

    (256 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
    AI/ML Overview
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    K Number
    K260697

    Validate with FDA (Live)

    Device Name
    VyPlate™ Anterior Cervical Plate System
    Manufacturer
    Vy Spine, LLC
    Date Cleared
    2026-03-27

    (23 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
    Intended Use
    Device Description
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