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

    THE TRABECULAR METAL BONE STABILIZATION IMPLANT, MODEL 99-11197-XX-10

    K Number: K050101 · Decision Apr 15, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    519
    Registration Numbers
    519
    Same Product Code
    1313
    Applicant Total
    10
    Review Days
    87

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    Basic Information

    Device Name
    THE TRABECULAR METAL BONE STABILIZATION IMPLANT, MODEL 99-11197-XX-10
    K Number
    K050101
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zimmer Trabecular
    Date Received
    January 18, 2005
    Decision Date
    April 15, 2005
    Product Code
    HRS
    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
    HRS Plate, Fixation, Bone

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    Other Clearances by Zimmer Trabecular

    K Number Device Name
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    K051756 MODIFICATION TO:TRABECULAR METAL FEMORAL CONE AUGMENTS, MODELS 03-125-ZZZZ
    K050766 EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM
    K050937 TRABECULAR METAL ACETABULAR REVISION SHELLS
    K042871 TRABECULAR METAL ACETABULAR AUGMENTS, MODELS 4894-XXX-YY, 02-212-105XX3, 02-212-205XX3, 02-212-305XX3
    K043061 THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, MODEL 4316-XX-XX