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

    TRABECULAR METAL TIBIAL CONE AUGMENTS

    K Number: K102896 · Decision Dec 13, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    219
    Registration Numbers
    219
    Same Product Code
    142
    Applicant Total
    11
    Review Days
    74

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    Basic Information

    Device Name
    TRABECULAR METAL TIBIAL CONE AUGMENTS
    K Number
    K102896
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3565
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zimmer Trabecular Metal Technology
    Date Received
    September 30, 2010
    Decision Date
    December 13, 2010
    Product Code
    MBH
    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
    MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

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    Other Clearances by Zimmer Trabecular Metal Technology

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    K093127 TRABECULAR METAL (TM) VERTEBRAL BODY REPLACEMENT (VBR) SYSTEM INSTRUMENT SET
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    K071090 TRABECULAR METAL GLENOID- B/F COMPLETE SHOULDER SOLUTION
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