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

    TOTAL TOE SYSTEM II

    K Number: K941650 · Decision Dec 19, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    10
    Applicant Total
    404
    Review Days
    258

    Basic Information

    Device Name
    TOTAL TOE SYSTEM II
    K Number
    K941650
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    BIOMET, INC.
    Date Received
    April 5, 1994
    Decision Date
    December 19, 1994
    Product Code
    LZJ
    Advisory Committee
    Unknown
    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
    LZJ Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained

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