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510(k) Data Aggregation

    K Number
    K121178
    Device Name
    TRANSCORP ACIF SYSTEM
    Manufacturer
    TRANSCORP, INC.
    Date Cleared
    2013-07-05

    (443 days)

    Product Code
    ODP
    Regulation Number
    888.3080
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRANSCORP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Transcorp ACIF System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level. DDD is defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. Transcorp ACIF implants are used to facilitate fusion in the cervical spine and are placed via an anterior approach at the C3 to C7 disc levels using autogenous bone graft. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral body fusion device. The device must be used with supplemental fixation.
    Device Description
    The proposed modified Transcorp Anterior Cervical Intervertebral Fusion (ACIF) System includes various size implants manufactured from implant grade Solvay Zeniva ZA-500 PEEK conforming to ASTM F2026-08. The implant is hollow to allow for autogenous bone graft material. The implant is provided non-sterile.
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    K Number
    K113352
    Device Name
    TRANSCORP SPINAL ACCESS SYSTEM
    Manufacturer
    TRANSCORP, INC.
    Date Cleared
    2012-04-16

    (154 days)

    Product Code
    HRX
    Regulation Number
    888.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRANSCORP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Transcorp Spinal Access System is indicated for minimally invasive visualization and access to the anterior spine for assisting in various surgical procedures such as herniated disc repair, biopsy, and harvesting autogenous bone.
    Device Description
    The Transcorp Spinal Access System is an instrument system used for minimally invasive visualization and access to the anterior spine. The system includes the following components: - Left and right orientation guides with 5°-15° of angulation - Fixation pins, 12-16mm - Drills, 2-6mm Diameter x 10-18mm Depth - Cannulated Drills, 2-6mm Diameter x 10-18mm Depth - Guide Pin Adapter - Guide Pins - Quick Disconnect Handle - Fixation Pin Driver - Tamp - Mallet
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    K Number
    K092794
    Device Name
    TRANSCORP ACIF SYSTEM
    Manufacturer
    TRANSCORP, INC.
    Date Cleared
    2010-09-13

    (367 days)

    Product Code
    ODP
    Regulation Number
    888.3080
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRANSCORP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Transcorp ACIF System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level. DDD is defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. Transcorp ACIF implants are used to facilitate fusion in the cervical spine and are placed via an anterior approach at the C3 to C7 disc levels using autogenous bone graft. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral body fusion device. The device must be used with supplemental fixation.
    Device Description
    The Transcorp Anterior Cervical Intervertebral Fusion (ACIF) System includes various size implants manufactured from implant grade PEEK conforming to ASTM F2026-08. The implant is hollow to allow for autogenous bone graft material. The implant is provided nonsterile.
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    K Number
    K092695
    Device Name
    TRANSCORP TRANS-PLATE ANTERIOR CERVICAL PLATE SYSTEM
    Manufacturer
    TRANSCORP, INC.
    Date Cleared
    2010-05-21

    (261 days)

    Product Code
    KWQ
    Regulation Number
    888.3060
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRANSCORP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Transcorp Trans-Plate Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7). These implants have been designed to provide stabilization to cervical fusion. Indications for the use of this implant system include degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudarthrosis, or failed previous fusion.
    Device Description
    The Transcorp Trans-Plate Anterior Cervical Plate System includes The Transoorp Trans Fivical plates and bone screws. The anterior cervical plate system includes a cover plate that covers the bone screws and the "window" of the plate. The cover plate is manufactured from implant grade PEEK conforming to ASTM F2026na. The plates, screws, and cover plate locking blade are manufactured from Titanium Alloy conforming to ASTM F136-08. The plate is fixated by attaching screws through holes in the plate to The plate is fixution of the vertebral body of the cervical spine (C2-C7).
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