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

    STALIF (TM) C

    K Number: K072415 · Decision Jan 25, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    230
    Registration Numbers
    230
    Same Product Code
    161
    Applicant Total
    10
    Review Days
    150

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    Basic Information

    Device Name
    STALIF (TM) C
    K Number
    K072415
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Surgicraft , Ltd.
    Date Received
    August 28, 2007
    Decision Date
    January 25, 2008
    Product Code
    OVE
    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
    OVE Intervertebral Fusion Device With Integrated Fixation, Cervical

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    Other Clearances by Surgicraft , Ltd.

    K Number Device Name
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    K072370 SURGICRAFT SURGICAL MESH SYSTEM
    K080447 SURGICRAFT SCREW FIXATION SYSTEM
    K073109 STALIF TT INTERVERTEBRAL BODY FUSION SYSTEM
    K051027 STALIF TT
    K041617 STALIF TT
    K991662 TITANIUM HARTSHILL SYSTEM
    K982719 THE BONE TIE
    K965221 RANSFORD CERVICAL FIXATION SYSTEM