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

    PATELLA PROSTHESIS

    K Number: K840100 · Decision Feb 9, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    315
    Registration Numbers
    315
    Same Product Code
    910
    Applicant Total
    31
    Review Days
    30

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    Basic Information

    Device Name
    PATELLA PROSTHESIS
    K Number
    K840100
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3560
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Techmedica, Inc.
    Date Received
    January 10, 1984
    Decision Date
    February 9, 1984
    Product Code
    JWH
    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
    JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

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    Other Clearances by Techmedica, Inc.

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    K923808 MULLER STRAIGHT STEM FEMORAL PROSTHESIS
    K926579 TECHMEDICA 6.5MM SELF-TAPPING CANCELLOUS BONE SCRE
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