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

    BIOFIX BIODEGRADABLE MENISCUS ARROW SYSTEM

    K Number: K955768 · Decision Mar 4, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    147
    Registration Numbers
    147
    Same Product Code
    219
    Applicant Total
    4
    Review Days
    73

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    Basic Information

    Device Name
    BIOFIX BIODEGRADABLE MENISCUS ARROW SYSTEM
    K Number
    K955768
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Bioscience, Inc.
    Date Received
    December 22, 1995
    Decision Date
    March 4, 1996
    Product Code
    MAI
    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
    MAI Fastener, Fixation, Biodegradable, Soft Tissue

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