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

    NEXFLEX FEMORAL STEM, STANDARD DESIGN

    K Number: K955170 · Decision Feb 9, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    266
    Registration Numbers
    266
    Same Product Code
    560
    Applicant Total
    6
    Review Days
    88

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    Basic Information

    Device Name
    NEXFLEX FEMORAL STEM, STANDARD DESIGN
    K Number
    K955170
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3358
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nexmed, Inc.
    Date Received
    November 13, 1995
    Decision Date
    February 9, 1996
    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 Nexmed, Inc.

    K Number Device Name
    K033580 NEXFLEX TOTAL HIP SYSTEM
    K991882 NEXFLEX TOTAL KNEE SYSTEM
    K955171 NEXLOCK FEMORAL STEM
    K952629 NEXFLEX TOTAL HIP SYSTEM
    K951656 NEXMED CANCELLOUS BONE SCREWS