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

    LSF* TOTAL HIP SYSTEM

    K Number: K855017 · Decision Jun 11, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    227
    Registration Numbers
    227
    Same Product Code
    562
    Applicant Total
    13
    Review Days
    177

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    Basic Information

    Device Name
    LSF* TOTAL HIP SYSTEM
    K Number
    K855017
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3350
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Implant Technology, Inc.
    Date Received
    December 16, 1985
    Decision Date
    June 11, 1986
    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 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
    K891472 IMPLANT TECHNOLOGY BONE CEMENT EXTRACTOR
    K884432 MODIFIED LSF TOTAL HIP SYSTEM
    K883212 LSF (R) TOTAL HIP SYSTEM - BIPOLAR COMPONENT
    K841546 COMMUNI-TRACH TUBE
    Search all 13 clearances from Implant Technology, Inc. →