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

    MODIFICATION TO:TRABECULAR METAL FEMORAL CONE AUGMENTS, MODELS 03-125-ZZZZ

    K Number: K051756 · Decision Jul 27, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    315
    Registration Numbers
    315
    Same Product Code
    910
    Applicant Total
    10
    Review Days
    28

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    Basic Information

    Device Name
    MODIFICATION TO:TRABECULAR METAL FEMORAL CONE AUGMENTS, MODELS 03-125-ZZZZ
    K Number
    K051756
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3560
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zimmer Trabecular
    Date Received
    June 29, 2005
    Decision Date
    July 27, 2005
    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 Zimmer Trabecular

    K Number Device Name
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    K052950 THE ZIMMER TMT TRABECULAR METAL VERTEBRAL BODY REPLACEMENT SYSTEM
    K050766 EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM
    K050937 TRABECULAR METAL ACETABULAR REVISION SHELLS
    K050101 THE TRABECULAR METAL BONE STABILIZATION IMPLANT, MODEL 99-11197-XX-10
    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