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

    EzFuze Implant System

    K Number: K150211 · Decision Nov 10, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    659
    Registration Numbers
    659
    Same Product Code
    1058
    Applicant Total
    7
    Review Days
    284

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    Basic Information

    Device Name
    EzFuze Implant System
    K Number
    K150211
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vilex IN Tennessee, Inc.
    Date Received
    January 30, 2015
    Decision Date
    November 10, 2015
    Product Code
    HWC
    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
    HWC Screw, Fixation, Bone

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    Other Clearances by Vilex IN Tennessee, Inc.

    K Number Device Name
    K191289 Bone Screw Line Addition
    K190543 Cannulated Hemi Implant
    K163487 Ultima HA Coated Half Pins and Wire
    K151881 X-Fix Line Additions
    K151456 Small Bone Nail Implant
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