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510(k) Data Aggregation

    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
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    Device Description
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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
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    K Number
    K252873

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    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
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    K Number
    K252623

    Validate with FDA (Live)

    Device Name
    G7® Revision Acetabular System
    Manufacturer
    Zimmer, Inc.
    Date Cleared
    2026-02-04

    (169 days)

    Product Code
    LPH,KWZ,LZO,OQG,OQH,OQI,PBI
    Regulation Number
    888.3358
    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
    K260038

    Validate with FDA (Live)

    Device Name
    E3D™-C Interbody System
    Manufacturer
    Evolution Spine
    Date Cleared
    2026-02-04

    (29 days)

    Product Code
    OVE
    Regulation Number
    888.3080
    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
    K250773

    Validate with FDA (Live)

    Device Name
    Luna® Ti Interbody Fusion System
    Manufacturer
    Spinal Elements, Inc.
    Date Cleared
    2026-02-04

    (327 days)

    Product Code
    MAX
    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
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    K Number
    K260104

    Validate with FDA (Live)

    Device Name
    Signature™ ONE System
    Manufacturer
    Orthosoft Inc. (d/b/a) Zimmer CAS
    Date Cleared
    2026-02-04

    (22 days)

    Product Code
    QHE,HSD,KWS,KWT,MBF,PHX
    Regulation Number
    888.3660
    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
    K250644

    Validate with FDA (Live)

    Device Name
    MSS - Monobloc stem
    Manufacturer
    Medacta International S.A.
    Date Cleared
    2026-02-03

    (336 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
    K252087

    Validate with FDA (Live)

    Device Name
    Navigation Module of the Cortium® System
    Manufacturer
    Ulrich Medical USA, Inc.
    Date Cleared
    2026-02-03

    (216 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
    K253640

    Validate with FDA (Live)

    Device Name
    T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System
    Manufacturer
    Stryker GmbH
    Date Cleared
    2026-02-03

    (76 days)

    Product Code
    HSB,HRS,HWC
    Regulation Number
    888.3020
    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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