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

    DURASUL BIPOLAR

    K Number: K040947 · Decision Aug 27, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    216
    Registration Numbers
    216
    Same Product Code
    98
    Applicant Total
    10
    Review Days
    137

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    Basic Information

    Device Name
    DURASUL BIPOLAR
    K Number
    K040947
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3390
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Centerpulse Orthopedics, Inc.
    Date Received
    April 12, 2004
    Decision Date
    August 27, 2004
    Product Code
    KWY
    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
    KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented

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    Other Clearances by Centerpulse Orthopedics, Inc.

    K Number Device Name
    K033943 ALPHA METASUL 28MM AND 32MM ACETABULAR INSERTS, STANDARD AND HOODED
    K033634 EPSILON METASUL 32MM ACETABULAR INSERTS, STANDARD AND HOODED
    K033810 NATURAL-KNEE II UNICOMPARTMENTAL KNEE SYSTEM
    K033664 MODIFICATION TO ALLOCLASSIC ZWEYMULLER SL OFFSET FEMORAL STEM
    K032348 CONVERGE RETI-LOCK MULTI-HOLE REINFORCEMENT CUP
    K030923 EPSILON DURASUL CONSTRAINED ACETABULAR LINER
    K032380 WAGNER CONE PROSTHESIS
    K031183 TIBIAL SPACER FOR THE NATURAL-KNEE II CEMENTED MODULAR TIBIAL BASEPLATE
    K030373 ALLOCLASSIC ZWEYMUELLER SL/SLL FEMORAL STEM