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

    IMPLANT TECHNOLOGY BONE CEMENT EXTRACTOR

    K Number: K891472 · Decision May 2, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    6
    Applicant Total
    13
    Review Days
    48

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    Basic Information

    Device Name
    IMPLANT TECHNOLOGY BONE CEMENT EXTRACTOR
    K Number
    K891472
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.4580
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Implant Technology, Inc.
    Date Received
    March 15, 1989
    Decision Date
    May 2, 1989
    Product Code
    LZV
    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
    LZV System, Cement Removal Extraction

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    Other Clearances by Implant Technology, Inc.

    K Number Device Name
    K921525 HIP JOINT METAL/POLYMER SEMI-CONSTRAINED PROTHESIS
    K915617 LSF HA COATED FEMORAL HIP
    K920021 LSF TOTAL HIP SYSTEM - MULLER-TYPE ACETABULAR CUP
    K913616 LSF DIAGNOSTIC RELATED GROUP CEMENTED HIP
    K902727 LSF CEMENTED FEMORAL HIP
    K901460 LSF(TM) TOTAL HIP SYSTEM
    K884432 MODIFIED LSF TOTAL HIP SYSTEM
    K883212 LSF (R) TOTAL HIP SYSTEM - BIPOLAR COMPONENT
    K855017 LSF* TOTAL HIP SYSTEM
    K841546 COMMUNI-TRACH TUBE
    Search all 13 clearances from Implant Technology, Inc. →