BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SOFAMOR ORTHOPAEDIC INSTRUMENTS

    K Number: K933242 · Decision Jan 28, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    1106
    Registration Numbers
    1106
    Same Product Code
    57
    Applicant Total
    56
    Review Days
    210

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    Basic Information

    Device Name
    SOFAMOR ORTHOPAEDIC INSTRUMENTS
    K Number
    K933242
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    888.4540
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Danek Medical, Inc.
    Date Received
    July 2, 1993
    Decision Date
    January 28, 1994
    Product Code
    LXH
    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
    LXH Orthopedic Manual Surgical Instrument

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