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

    SPINESMITH CYNCH SPINAL SYSTEM

    K Number: K101085 · Decision Jul 1, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    418
    Registration Numbers
    418
    Same Product Code
    890
    Applicant Total
    9
    Review Days
    73

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    Basic Information

    Device Name
    SPINESMITH CYNCH SPINAL SYSTEM
    K Number
    K101085
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Spine Smith Partners L.P.
    Date Received
    April 19, 2010
    Decision Date
    July 1, 2010
    Product Code
    MAX
    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
    MAX Intervertebral Fusion Device With Bone Graft, Lumbar

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    Other Clearances by Spine Smith Partners L.P.

    K Number Device Name
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    K090376 SPINESMITH CYNCH SPINAL SYSTEM
    K082821 SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYSTEM
    K081132 SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYSTEM
    K080971 SPINESMITH CIMPLICITY SPINAL SYSTEM
    K073320 CIMPLICITY SPINAL SYSTEM