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

    ORTHOSORB(TM) ABSORBABLE CEMENT RESTRICTOR

    K Number: K932595 · Decision Sep 20, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    36
    Applicant Total
    22
    Review Days
    480

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    Basic Information

    Device Name
    ORTHOSORB(TM) ABSORBABLE CEMENT RESTRICTOR
    K Number
    K932595
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Johnson & Johnson Orthopaedics, Inc.
    Date Received
    May 28, 1993
    Decision Date
    September 20, 1994
    Product Code
    LZN
    Advisory Committee
    General, Plastic Surgery
    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
    LZN Cement Obturator

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