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510(k) Data Aggregation

    K Number
    K181589
    Device Name
    Curiteva Lumbar Interbody Fusion System
    Manufacturer
    Curiteva, LLC
    Date Cleared
    2018-12-20

    (185 days)

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

    Curiteva, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Curiteva Lumbar Interbody Fusion is indicated for use in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 - S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Implants are intended to be used with autograft and/or allograft bone (comprised of cancellous and/or corticocancellous bone graft) and supplemental spinal fixation systems that have been cleared for use in the lumbar spine. Patients should receive at least six (6) months of non-operative treatment prior to treatment with the device.
    Device Description
    The Curiteva Lumbar Interbody Fusion System implants are available in a variety of different footprints, styles and sizes to accommodate surgical approach, and the individual pathology and anatomical conditions of the patient. The implants are generally rectangle-shaped with an open central chamber to permit packing with bone graft to facilitate fusion. The superior and inferior surfaces of the construct have a pattern of teeth to provide increased stability and to help prevent movement of the device. The Curiteva Lumbar Interbody Fusion System implants are manufactured from PEEK (per ASTM F2026) with Tantalum markers (per ASTM F560), or Titanium alloy (Ti-6Al-4V) that conforms to ASTM F136. The PEEK implants are available with or without a medical grade commercially pure titanium (CpTi) plasma coating (per ASTM F1580) on the superior and inferior surfaces.
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    K Number
    K181549
    Device Name
    Curiteva Midline Anterior Cervical Plate System (or Curiteva Anterior Cervical Plate System)
    Manufacturer
    Curiteva, LLC
    Date Cleared
    2018-08-03

    (52 days)

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

    Curiteva, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Curiteva Midline Anterior Cervical Plate System is intended for anterior fixation of the cervical spine (C2-T1) as an adjunct to fusion. The system is intended to provide temporary stabilization during the development of cervical spinal fusion in patients with the following: degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformity (e.g., kyphosis, scoliosis), tumors, pseudarthrosis, and/or failed previous fusion.
    Device Description
    The Curiteva Midline Anterior Cervical Plate System consists of screws and plates. These implants are available in different sizes so that adaptations can be made to take into account pathology and individual patient anatomy. All implants are manufactured from Titanium alloy (Ti-6Al-4V) that conforms to ASTM F136 and are provided non-sterile.
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    K Number
    K181562
    Device Name
    Curiteva Anterior Cervical Plate System
    Manufacturer
    Curiteva, LLC
    Date Cleared
    2018-08-02

    (49 days)

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

    Curiteva, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Curiteva Anterior Cervical Plate System is intended for anterior fixation of the cervical spine (C2-T1) as an adjunct to fusion. The system is intended to provide temporary stabilization during the development of cervical spinal fusion in patients with the following: degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radios), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformity (e.g., kyphosis, lordosis, scoliosis), tumors, pseudarthrosis, and/or failed previous fusion.
    Device Description
    The Curiteva Anterior Cervical Plate System consists of screws and plates. These implants are available in different sizes so that adaptations can be made to take into account pathology and individual patient anatomy. All implants are manufactured from Titanium alloy (Ti-6Al-4V) that conforms to ASTM F136.
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    K Number
    K181261
    Device Name
    Curiteva Cervical Interbody Fusion System
    Manufacturer
    Curiteva, LLC
    Date Cleared
    2018-07-09

    (59 days)

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

    Curiteva, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Curiteva Cervical Interbody Fusion is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level (C2 - T1 inclusive). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. Implants are intended to be used with autograft bone (comprised of cancellous and/or corticocancellous bone graft) and supplemental spinal fixation systems that have been cleared for use in the cervical spine. Patients should receive at least six (6) weeks of non-operative treatment with the device.
    Device Description
    The Curiteva Cervical Interbody Fusion System implants are available in a variety of different footprints, styles and sizes to accommodate the individual pathology and anatomical conditions of the patient. The implants are generally box-shaped with an open central chamber to permit packing with bone graft to facilitate fusion. The superior and inferior surfaces of the construct have a pattern of teeth to provide increased stability and to help prevent movement of the device. The Curiteva Cervical Interbody Fusion System implants are manufactured from PEEK (per ASTM F2026) with Tantalum markers (per ASTM F560), or Titanium alloy (Ti-6Al-4V) that conforms to ASTM F136. The PEEK implants are available with or without a medical grade commercially pure titanium (CpTi) plasma coating (per ASTM F1580) on the superior and inferior surfaces.
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