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

    TECHMEDICA CAD/CAM CUSTOM HIP

    K Number: K911058 · Decision Feb 23, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    227
    Registration Numbers
    227
    Same Product Code
    562
    Applicant Total
    31
    Review Days
    718

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    Basic Information

    Device Name
    TECHMEDICA CAD/CAM CUSTOM HIP
    K Number
    K911058
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3350
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Techmedica, Inc.
    Date Received
    March 8, 1991
    Decision Date
    February 23, 1993
    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 Techmedica, Inc.

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    K926387 TECHMEDICA STANDARD CEMENTED HIP SYSTEM
    K925420 TECHMEDICA STANDARD BIPOLAR SYSTEM
    K923808 MULLER STRAIGHT STEM FEMORAL PROSTHESIS
    K926579 TECHMEDICA 6.5MM SELF-TAPPING CANCELLOUS BONE SCRE
    K925181 TECHMEDICA MUELLER TYPE POLYETHYLENE ACETBUL CUP
    K920080 CONTINUUM KNEE SYSTEM
    K921458 TMP MICROPLATING SYSTEM
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