BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Stryker Orthopaedics Hip Devices Labeling Update

    K Number: K243784 · Decision Feb 6, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    266
    Registration Numbers
    266
    Same Product Code
    560
    Applicant Total
    30
    Review Days
    59

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    Basic Information

    Device Name
    Stryker Orthopaedics Hip Devices Labeling Update
    K Number
    K243784
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3358
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Howmedica Osteonics Corp., Dba Stryker Orthopaedics
    Date Received
    December 9, 2024
    Decision Date
    February 6, 2025
    Product Code
    LPH
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

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    Other Clearances by Howmedica Osteonics Corp., Dba Stryker Orthopaedics

    K Number Device Name
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