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

    EXPANDABLE KNEE

    K Number: K020381 · Decision May 6, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    137
    Registration Numbers
    137
    Same Product Code
    85
    Applicant Total
    34
    Review Days
    90

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    Basic Information

    Device Name
    EXPANDABLE KNEE
    K Number
    K020381
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3510
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biomet Orthopedics, Inc.
    Date Received
    February 5, 2002
    Decision Date
    May 6, 2002
    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 Biomet Orthopedics, Inc.

    K Number Device Name
    K080528 E-POLY TIBIAL BEARINGS
    K072879 INNERVUE DIAGNOSTIC SCOPE SYSTEM
    K070955 ACID ETCHED LAG SCREWS
    K033355 LACTOSCREW SCREW ANCHOR
    K032286 CALCIGEN PSI BONE GRAFT SUBSTITUTE
    K030048 HA PMI FEMORAL HIP STEM
    K024086 PROPELLER HEAD SMALL CANNULATED SCREW SYSTEM
    K023063 COMPREHENSIVE HUMERAL FRACTURE SYSTEM
    K023188 PRESS-FIT HEAD RESURFACING DEVICE
    K023357 ARCPM 1050 RESIN-HIPS
    Search all 34 clearances from Biomet Orthopedics, Inc. →