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

    Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid Tibial

    K Number: K142814 · Decision Jun 25, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    227
    Registration Numbers
    227
    Same Product Code
    562
    Applicant Total
    2
    Review Days
    269

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    Basic Information

    Device Name
    Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid Tibial
    K Number
    K142814
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3350
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biomet Manufacturing, LLC
    Date Received
    September 29, 2014
    Decision Date
    June 25, 2015
    Product Code
    JDI
    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
    JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

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    Other Clearances by Biomet Manufacturing, LLC

    K Number Device Name
    K140509 BIOMET SIDE ACCESS DISTAL FEMORAL EXPANDABLE