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

    FURLONG H-AC TOTAL HIP REPLACEMENT SYSTEM

    K Number: K041353 · Decision Oct 8, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    189
    Registration Numbers
    189
    Same Product Code
    158
    Applicant Total
    1
    Review Days
    141

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    Basic Information

    Device Name
    FURLONG H-AC TOTAL HIP REPLACEMENT SYSTEM
    K Number
    K041353
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3353
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Jri Manufacturing, Ltd.
    Date Received
    May 20, 2004
    Decision Date
    October 8, 2004
    Product Code
    MEH
    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
    MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate

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