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

    DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATION

    K Number: K980926 · Decision Dec 16, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    231
    Registration Numbers
    231
    Same Product Code
    560
    Applicant Total
    373
    Review Days
    280

    Basic Information

    Device Name
    DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATION
    K Number
    K980926
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3350
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    HOWMEDICA CORP.
    Date Received
    March 11, 1998
    Decision Date
    December 16, 1998
    Product Code
    JDI
    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
    JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

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    Other Clearances by HOWMEDICA CORP.

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    K980626 DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATION
    K980632 DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION
    K983419 HOFFMANN II MIAMI POST
    K982958 ZETA MULTIZONE LOCKING NAIL SYSTEM
    K982873 ZETA MULTIZONE SCN LOCKING NAIL
    K982531 HOWMEDICA LEIBINGER RESORBABLE FIXATION SYSTEM
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