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

    HINGED KNEE

    K Number: K982160 · Decision Mar 17, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    137
    Registration Numbers
    137
    Same Product Code
    85
    Applicant Total
    85
    Review Days
    271

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    Basic Information

    Device Name
    HINGED KNEE
    K Number
    K982160
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3510
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Encore Orthopedics, Inc.
    Date Received
    June 19, 1998
    Decision Date
    March 17, 1999
    Product Code
    KRO
    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
    KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer

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    Other Clearances by Encore Orthopedics, Inc.

    K Number Device Name
    K032905 3DKNEE POROUS COATED FEMORAL COMPONENT
    K020114 3D KNEE
    K020741 UNICONDYLAR KNEE
    K020236 MODIFICATION TO PASS SPINAL SYSTEM
    K020170 KEYSTONE HIP SYSTEM CALCAR REPLACEMENT BODY AND BUILD UP
    K013490 CEMENTED CALCAR HIP SYSTEM
    K013442 PASS SPINAL SYSTEM
    K003324 PLASMA SPRAYED SHOULDER
    K013431 PASS SPINAL SYSTEM
    K013191 PASS SPINAL SYSTEM
    Search all 85 clearances from Encore Orthopedics, Inc. →