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

    Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti

    K Number: K150643 · Decision Jun 8, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    253
    Registration Numbers
    253
    Same Product Code
    200
    Applicant Total
    10
    Review Days
    88

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti
    K Number
    K150643
    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
    March 12, 2015
    Decision Date
    June 8, 2015
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (OVD), ordered by most recent decision date.

    Anteralign LS coverplate

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MectaLIF 3D Metal Anterior

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SCRIPT™ Implant System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Ventana™ A Anterior Lumbar Interbody System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DeGen Medical Patient Specific Implant (PSI) System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody System

    FDA 510(k)
    FDA Class 2 ·Orthopedic
    View all

    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
    K141942 MIDLINE II TI
    K142079 STALIF CTI, STALIF C
    K133200 STALIF C(R)
    K133286 MIDLINE (TM)
    K130461 STALIF X
    K120819 STALIF C