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

    OMNI Skirted Heads

    K Number: K152919 · Decision Mar 10, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    276
    Registration Numbers
    276
    Same Product Code
    530
    Applicant Total
    21
    Review Days
    160

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    Basic Information

    Device Name
    OMNI Skirted Heads
    K Number
    K152919
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3353
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Omni Life Science, Inc.
    Date Received
    October 2, 2015
    Decision Date
    March 10, 2016
    Product Code
    LZO
    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
    LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

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    K111184 APEX PS KNEE SYSTEM - PS-C INSERT
    K110947 APEX K1 HIP STEM
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