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

    E-POLY TIBIAL BEARINGS

    K Number: K080528 · Decision Jun 17, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    315
    Registration Numbers
    315
    Same Product Code
    910
    Applicant Total
    34
    Review Days
    112

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    Basic Information

    Device Name
    E-POLY TIBIAL BEARINGS
    K Number
    K080528
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3560
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biomet Orthopedics, Inc.
    Date Received
    February 26, 2008
    Decision Date
    June 17, 2008
    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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