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

    SPINESMITH CIMPLICITY SPINAL SYSTEM

    K Number: K080971 · Decision Jul 2, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    222
    Registration Numbers
    222
    Same Product Code
    276
    Applicant Total
    9
    Review Days
    89

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    Basic Information

    Device Name
    SPINESMITH CIMPLICITY SPINAL SYSTEM
    K Number
    K080971
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3060
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Spine Smith Partners L.P.
    Date Received
    April 4, 2008
    Decision Date
    July 2, 2008
    Product Code
    MQP
    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
    MQP Spinal Vertebral Body Replacement Device

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    Other Clearances by Spine Smith Partners L.P.

    K Number Device Name
    K122630 IN:C2 SPINAL FIXATION SYSTEM
    K122168 VISUALIF CHALLENGING ACCESS PLATE
    K102090 SPINESMITH CYNCH SPINAL SYSTEM - VISUALIF INTERBODY FUSION IMPLANT SYSTEM
    K101085 SPINESMITH CYNCH SPINAL SYSTEM
    K090376 SPINESMITH CYNCH SPINAL SYSTEM
    K082821 SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYSTEM
    K081132 SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYSTEM
    K073320 CIMPLICITY SPINAL SYSTEM