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

    STALIF X

    K Number: K130461 · Decision Aug 28, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    253
    Registration Numbers
    253
    Same Product Code
    200
    Applicant Total
    10
    Review Days
    187

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    Basic Information

    Device Name
    STALIF X
    K Number
    K130461
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Centinel Spine, Inc.
    Date Received
    February 22, 2013
    Decision Date
    August 28, 2013
    Product Code
    OVD
    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
    OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar

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    Other Clearances by Centinel Spine, Inc.

    K Number Device Name
    K173347 STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX, ACTILIF M FLX, ACTILIF L FLX and ACTILIF Lateral-Oblique FLX
    K152211 PCT System
    K150053 STALIF C; STALIF C-Ti
    K150643 Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti
    K141942 MIDLINE II TI
    K142079 STALIF CTI, STALIF C
    K133200 STALIF C(R)
    K133286 MIDLINE (TM)
    K120819 STALIF C