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510(k) Data Aggregation

    K Number
    K251900

    Validate with FDA (Live)

    Device Name
    MY01 Continuous Compartmental Pressure Monitor
    Manufacturer
    MY01, Inc.
    Date Cleared
    2026-01-16

    (210 days)

    Product Code
    LXC
    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
    Intended Use
    Device Description
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    K Number
    K251714

    Validate with FDA (Live)

    Device Name
    Ion-C
    Manufacturer
    SurGenTec, LLC
    Date Cleared
    2026-01-16

    (227 days)

    Product Code
    MRW
    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
    K252205

    Validate with FDA (Live)

    Device Name
    Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody System; Curiteva Porous PEEK Laminoplasty System; Curiteva Porous PEEK Standalone ALIF System
    Manufacturer
    Curiteva, Inc.
    Date Cleared
    2026-01-16

    (186 days)

    Product Code
    ODP,MAX,NQW,OVD,PHM
    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
    K252516

    Validate with FDA (Live)

    Device Name
    N22 EZ Glenosphere
    Manufacturer
    Shoulder Innovations, Inc.
    Date Cleared
    2026-01-15

    (157 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
    K251961

    Validate with FDA (Live)

    Device Name
    SDS Growing Rod
    Manufacturer
    BAAT Medical Products B.V.
    Date Cleared
    2026-01-15

    (203 days)

    Product Code
    PGM
    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
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    K Number
    K253171

    Validate with FDA (Live)

    Device Name
    Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)
    Manufacturer
    Maxx Orthopedics, Inc.
    Date Cleared
    2026-01-15

    (111 days)

    Product Code
    LZO,MEH,OQI
    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
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    K Number
    K254061

    Validate with FDA (Live)

    Device Name
    Curiteva Porous PEEK Cervical Interbody Fusion System
    Manufacturer
    Curiteva, Inc.
    Date Cleared
    2026-01-15

    (29 days)

    Product Code
    ODP
    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
    Intended Use
    Device Description
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    K Number
    K252567

    Validate with FDA (Live)

    Device Name
    AltiVate Reverse® ADLC Glenosphere
    Manufacturer
    Encore Medical, L.P.
    Date Cleared
    2026-01-15

    (154 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
    AI/ML Overview
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    K Number
    K254002

    Validate with FDA (Live)

    Device Name
    TriMed Volar Bearing Plates (VBEAL-13-7S); TriMed Volar Bearing Plates (VBEAR-13-7S); TriMed Volar Bearing Plates (VBEAL-14-7S); TriMed Volar Bearing Plates (VBEAR-14-7S); TriMed Volar Bearing Plates (VBEAL-16-7S); TriMed Volar Bearing Plates (VBEAR-16-7S)
    Manufacturer
    TriMed, Inc.
    Date Cleared
    2026-01-15

    (31 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
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    K Number
    K252219

    Validate with FDA (Live)

    Device Name
    Cervical Interbody and VBR Fusion System
    Manufacturer
    Sync Surgical
    Date Cleared
    2026-01-14

    (183 days)

    Product Code
    ODP,MQP,PLR
    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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