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

    Progressive Orthopaedic Total Hip System

    K Number: K143314 · Decision Feb 27, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    266
    Registration Numbers
    266
    Same Product Code
    560
    Applicant Total
    5
    Review Days
    100

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    Basic Information

    Device Name
    Progressive Orthopaedic Total Hip System
    K Number
    K143314
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3358
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    The Progressive Orthopaedic Company, LLC
    Date Received
    November 19, 2014
    Decision Date
    February 27, 2015
    Product Code
    LPH
    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
    LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

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    Other Clearances by The Progressive Orthopaedic Company, LLC

    K Number Device Name
    K183344 The Progressive Orthopaedic Company Total Knee System II
    K151424 The Progressive Orthopaedic Total Hip System
    K150783 Progressive Orthopaedic Total Knee System
    K142649 Progressive Orthopedic Total Knee System