BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    BENVENUE VCF OSTEO COIL SYSTEM

    K Number: K070293 · Decision Jul 10, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    48
    Registration Numbers
    48
    Same Product Code
    0
    Applicant Total
    8
    Review Days
    160

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    Basic Information

    Device Name
    BENVENUE VCF OSTEO COIL SYSTEM
    K Number
    K070293
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    888.4540
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Benvenue Medical, Inc.
    Date Received
    January 31, 2007
    Decision Date
    July 10, 2007
    Product Code
    OCJ
    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
    OCJ Spinal Channeling Instrument, Vertebroplasty

    Other Clearances by Benvenue Medical, Inc.

    K Number Device Name
    K201427 Trivergent Spinal Fixation System
    K193172 Luna XD Ti Interbody Fusion System
    K183560 Luna 3D GEN2 Interbody Fusion System
    K162431 Luna 3D Interbody Fusion System
    K142023 LUNA INTERBODY SYSTEM
    K141141 KIVA VCF TREATMENT SYSTEM
    K132817 KIVA VCF TREATMENT SYSTEM