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

    Avenue T TLIF Cage

    K Number: K142645 · Decision Jun 11, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    253
    Registration Numbers
    253
    Same Product Code
    200
    Applicant Total
    10
    Review Days
    267

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    Basic Information

    Device Name
    Avenue T TLIF Cage
    K Number
    K142645
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ldr Spine USA, Inc.
    Date Received
    September 17, 2014
    Decision Date
    June 11, 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

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    Other Clearances by Ldr Spine USA, Inc.

    K Number Device Name
    K162133 VerteFIT Corpectomy Cage System
    K161173 Avenue® T TLIF Cage
    K161798 FacetBRIDGE® System
    K133363 INTERBRIDGE INTERSPINOUS POSTERIOR FIXATION SYSTEM
    K123134 EASYSPINE SYSTEM
    K121103 LDR SPINE USA SPINE TUNE, TL SPINAL SYSTEM, LDR SPINE USA EASYSPINE, POSTERIOR SPINAL SYSTEM, LDR SPINE USA MC IMPLANT S
    K113285 LDR SPINE USA AVENUE L INTERBODY FUSION
    K120760 LDR SPINE SPINETUNE TL SPINAL SYSTEM
    K113559 LDR SPINE CERVICAL INTERBODY FUSION SYSTME-ROI-C LORDOTIC IMPLANTS