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

    FitRite™ Total Hip Arthroplasty System

    K Number: K153057 · Decision Jun 23, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    227
    Registration Numbers
    227
    Same Product Code
    562
    Applicant Total
    2
    Review Days
    246

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    Basic Information

    Device Name
    FitRite™ Total Hip Arthroplasty System
    K Number
    K153057
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3350
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Excera Orthopedics, Inc.
    Date Received
    October 21, 2015
    Decision Date
    June 23, 2016
    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 Excera Orthopedics, Inc.

    K Number Device Name
    K140547 EXCERA FITRITE TOTAL HIP ARTHROPLASTY SYSTEM