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

    MLI SOFT TISSUE SCREW & WASHER SYSTEM

    K Number: K962194 · Decision Jul 30, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    275
    Registration Numbers
    275
    Same Product Code
    593
    Applicant Total
    8
    Review Days
    53

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    Basic Information

    Device Name
    MLI SOFT TISSUE SCREW & WASHER SYSTEM
    K Number
    K962194
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medicinelodge, Inc.
    Date Received
    June 7, 1996
    Decision Date
    July 30, 1996
    Product Code
    MBI
    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
    MBI Fastener, Fixation, Nondegradable, Soft Tissue

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    Other Clearances by Medicinelodge, Inc.

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    K961920 CROSS PIN
    K961905 MEDICINELODGE, INC. SET SCREW
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    K953350 MLI INTERFERENCE SCREW