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

    MESH FENESTRATED INTRODUCER NEEDLE (MESH INTRODUCER NEEDLE)

    K Number: K071375 · Decision Dec 21, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    107
    Applicant Total
    16
    Review Days
    219

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    Basic Information

    Device Name
    MESH FENESTRATED INTRODUCER NEEDLE (MESH INTRODUCER NEEDLE)
    K Number
    K071375
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3027
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Disc-O-Tech Medical Technologies, Ltd.
    Date Received
    May 16, 2007
    Decision Date
    December 21, 2007
    Product Code
    NDN
    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
    NDN Cement, Bone, Vertebroplasty

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    Other Clearances by Disc-O-Tech Medical Technologies, Ltd.

    K Number Device Name
    K071679 METAFIX AND FIXION FA INTRAMEDULLARY NAILING SYSTEMS
    K063067 CONFIDENCE FENESTRATED INTRODUCER NEEDLE
    K062424 CONFIDENCE EX HIGH VISCOSITY BONE CEMENT
    K060300 CONFIDENCE HIGH VISCOSITY BONE CEMENT
    K040612 SKY BONE EXPANDER SYSTEM (SKY SYSTEM)
    K040939 SKY BONE EXPANDER SYSTEM (SKY SYSTEM)
    K032730 FIXION HIP SYSTEM
    K034037 SKY BONE EXPANDER SYSTEM
    K032358 B-TWIN BONE EXPANDER SYSTEM (B-TWIN BE SYSTEM)
    K030972 FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION MH)
    Search all 16 clearances from Disc-O-Tech Medical Technologies, Ltd. →