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

    Summit Hip System

    K Number: K170339 · Decision Apr 26, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    284
    Registration Numbers
    284
    Same Product Code
    522
    Applicant Total
    7
    Review Days
    448

    Basic Information

    Device Name
    Summit Hip System
    K Number
    K170339
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3353
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    DePuy Orthopaedics, Inc.
    Date Received
    February 2, 2017
    Decision Date
    April 26, 2018
    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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