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

    TRABECULAR METAL ACETABULAR REVISION SHELLS

    K Number: K050937 · Decision May 11, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    266
    Registration Numbers
    266
    Same Product Code
    560
    Applicant Total
    10
    Review Days
    27

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    Basic Information

    Device Name
    TRABECULAR METAL ACETABULAR REVISION SHELLS
    K Number
    K050937
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3358
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zimmer Trabecular
    Date Received
    April 14, 2005
    Decision Date
    May 11, 2005
    Product Code
    LPH
    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
    LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

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    K052950 THE ZIMMER TMT TRABECULAR METAL VERTEBRAL BODY REPLACEMENT SYSTEM
    K051756 MODIFICATION TO:TRABECULAR METAL FEMORAL CONE AUGMENTS, MODELS 03-125-ZZZZ
    K050766 EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM
    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