BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇧🇪 Belgium

    ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, VERSION 2.0

    K Number: K093533 · Decision Feb 17, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    219
    Registration Numbers
    219
    Same Product Code
    142
    Applicant Total
    61
    Review Days
    93

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    Basic Information

    Device Name
    ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, VERSION 2.0
    K Number
    K093533
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3565
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Materialise NV
    Date Received
    November 16, 2009
    Decision Date
    February 17, 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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