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510(k) Data Aggregation

    K Number
    K243137
    Device Name
    Curiteva Porous PEEK Laminoplasty System
    Manufacturer
    Curiteva, Inc.
    Date Cleared
    2024-10-28

    (28 days)

    Product Code
    NQW, NOW
    Regulation Number
    888.3050
    Why did this record match?
    Product Code :

    NQW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Curiteva Porous PEEK Laminoplasty System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The Curiteva Porous PEEK Laminoplasty System is used to hold or buttress the allograft or autograft material in place in order to prevent the graft material from expulsion or impinging the spinal cord.
    Device Description
    The Curiteva Porous PEEK Laminoplasty System is an internal fixation device for spinal surgery that consists of various configurations of plates and screws. The implant configurations are available in different types and sizes so that adaptations can be made to take into account pathology and individual patient anatomy. The plates come preformed with holes to receive bone screws. Screws are used to attach the plates to bone. System plate configurations may be used with allograft or autograft material. A hinge plate is provided when additional stabilization is necessary. All system components are manufactured from Titanium alloy (Ti-6A1-4V ELI) that conforms to ASTM F136, or PEEK (Polyetheretherketone) as described by ASTM F2026. The Curiteva Porous PEEK Laminoplasty implants are sterile, single-use devices and available in a variety of different sizes to accommodate the individual pathology and anatomical conditions of the patient. The implants have solid and porous PEEK regions. The Curiteva Porous PEEK Laminoplasty implants are manufactured from implant-grade PEEK (per ASTM F2026). Each porous PEEK implant has been surface treated with a hydroxyapatite (HA) coating that is approximately 20nm thick.
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    K Number
    K242784
    Device Name
    Vy Spine™ VyLam™ Laminoplasty System
    Manufacturer
    Vy Spine, LLC
    Date Cleared
    2024-10-16

    (30 days)

    Product Code
    NQW, NOW
    Regulation Number
    888.3050
    Why did this record match?
    Product Code :

    NQW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vy Spine™ VyLam™ Laminoplasty System is indicated for use in laminoplasty of the lower cervical and upper thoracic spine (C3 to T3) in skeletally mature patients. The system devices are designed for use with allogenic bone graft in order to prevent the allograft from expulsion or impinging on the spinal cord. One device may be used per vertebra.
    Device Description
    The Vy Spine™ VyLam™ Laminoplasty System is comprised of implant and instrument components. The implant components, plates and screws, will hold the decompression after a laminoplasty procedure. The implant components are manufactured from Ti-6Al-4V ELI per ASTM F136 and are available in multiple anatomical sizes to accommodate various vertebral bodies. The instruments are manufactured from stainless steel per ASTM F899, high grade plastic, and silicone rubber.
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    K Number
    K232471
    Device Name
    Vy Spine™ VyLam™ Laminoplasty System
    Manufacturer
    Vy Spine, LLC
    Date Cleared
    2023-10-10

    (55 days)

    Product Code
    NQW, NOW
    Regulation Number
    888.3050
    Why did this record match?
    Product Code :

    NQW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vy Spine™ VyLam™ Laminoplasty System is indicated for use in laminoplasty of the lower cervical and upper thoracic spine (C3 to T3) in skeletally mature patients. The system devices are designed for use with allogenic bone graft in order to prevent the allograft from expulsion or impinging on the spinal cord. One device may be used per vertebra.
    Device Description
    The Vy Spine™ VyLam™ Laminoplasty System is comprised of implant and instrument components. The implant components, plates and screws, will hold the decompression after a laminoplasty procedure. The implant components are manufactured from Ti-6Al-4V ELI per ASTM F136 and are available in multiple anatomical sizes to accommodate various vertebral bodies. The instruments are manufactured from stainless steel per ASTM F899, high grade plastic, and silicone rubber.
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    K Number
    K231232
    Device Name
    Curiteva Laminoplasty System
    Manufacturer
    Curiteva, Inc.
    Date Cleared
    2023-06-28

    (61 days)

    Product Code
    NQW
    Regulation Number
    888.3050
    Why did this record match?
    Product Code :

    NQW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Curiteva Laminoplasty System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The Curiteva Laminoplasty System is used to hold or buttress the allograft material in place in order to prevent the graft material from expulsion or impinging the spinal cord.
    Device Description
    The Curiteva Laminoplasty System is an internal fixation device for spinal surgery that consists of various configurations of plates and screws. The implant configurations are available in different types and sizes so that adaptations can be made to take into account pathology and individual patient anatomy. The plates come preformed with holes to receive bone screws. Screws are used to attach the plates to bone. System plate configurations may be used with allograft or autograft material. A hinge plate is provided when additional stabilization is necessary. All system components are manufactured from Titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136, or PEEK (Polyetheretherketone) as described by ASTM F2026.
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    K Number
    K212428
    Device Name
    Centerpiece Plate Fixation System
    Manufacturer
    Medtronic Sofamor Danek
    Date Cleared
    2021-12-13

    (131 days)

    Product Code
    NQW
    Regulation Number
    888.3050
    Why did this record match?
    Product Code :

    NQW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CENTERPIECE™ Plate Fixation System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The CENTERPIECE™ Plate Fixation System is used to hold the graft material in place in order to prevent the graft material from expulsion or impinging the spinal cord.
    Device Description
    The CENTERPIECE™ Plate Fixation System consists of a variety of sizes of plates and screws. The CENTERPIECE™ Plate Fixation System screws are made of from medical grade titanium or titanium alloy. Screws will be provided sterile and non-sterile and are reusable.
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    K Number
    K191927
    Device Name
    Hinged Laminoplasty System
    Manufacturer
    Life Spine, Inc.
    Date Cleared
    2019-09-20

    (63 days)

    Product Code
    NQW
    Regulation Number
    888.3050
    Why did this record match?
    Product Code :

    NQW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Life Spine Hinged Laminoplasty System is indicated for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The Life Spine Hinged Laminoplasty System is used to hold or butresses the allograft or autograft material in place to prevent the graft material from expulsion or impinging the spinal cord.
    Device Description
    The Life Spine Hinged Laminoplasty System consists of various plates and screw configurations to address surgeon and patient needs. The plates have screw holes at the ends that allow attachment to bone. The center hole of the plate allows it to be affixed to allograft or autograft material. All components are fabricated and manufactured from titanium alloy 6AL-4V-ELI per ASTM F-136. All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Life Spine Hinged Laminoplasty System components with components from any other system or manufacturer. The Life Spine Laminoplasty System components should never be reused under any circumstances.
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    K Number
    K191169
    Device Name
    NuVasive® Camber Laminoplasty System
    Manufacturer
    NuVasive, Incorporated
    Date Cleared
    2019-07-03

    (63 days)

    Product Code
    NQW
    Regulation Number
    888.3050
    Why did this record match?
    Product Code :

    NQW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NuVasive® Camber Laminoplasty System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The Camber Laminoplasty System is used to hold the allograft or autograft material in place in order to prevent the allograft or autograft material from expulsion, or impinging the spinal cord.
    Device Description
    The NuVasive® Camber Laminoplasty System consists of plates and screws of various sizes made from titanium alloy (ASTM F136) to provide reinforcement while expanding the spinal canal and preserving the posterior elements. Instruments required to implant the device are also available.
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    K Number
    K181717
    Device Name
    Life Spine Laminoplasty System
    Manufacturer
    Life Spine Inc.
    Date Cleared
    2018-10-12

    (106 days)

    Product Code
    NQW
    Regulation Number
    888.3050
    Why did this record match?
    Product Code :

    NQW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Life Spine Laminoplasty System is indicated for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The Life Spine Laminoplasty System holds or buttresses the allograft in place in order to prevent the allograft from expulsion or impinging on the spinal cord.
    Device Description
    The Life Spine Laminoplasty System consists of plates screws in various diameters and lengths to support a laminoplasty procedure. All components are fabricated and manufactured from titanium alloy 6AL-4V-ELI per ASTM F-136. All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Life Spine Laminoplasty System components with components from any other system or manufacturer. The Life Spine Laminoplasty System components should never be reused under any circumstances.
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    K Number
    K173215
    Device Name
    Choice Spine Laminoplasty™ Fixation System
    Manufacturer
    Choice Spine, LP
    Date Cleared
    2018-01-19

    (109 days)

    Product Code
    NQW, NOW
    Regulation Number
    888.3050
    Why did this record match?
    Product Code :

    NQW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Choice Spine Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The Choice Spine Laminoplasty Fixation System is used to hold or buttress the allograft or autograft material in place in order to prevent the graft material from expulsion or impinging the spinal cord.
    Device Description
    The proposed Choice Spine Laminoplasty Fixation System is an implant system that consists of various plates and screw configurations. The proposed plates are available in various configurations to address surgeon and patient needs as necessary. The proposed plate devices come preformed with holes for bone screws. The plate offered can be affixed to allograft or autograft material and secured with a bone screw from the system. A hinge plate is provided when additional stabilization is necessary. Screws are used to attach the plates to bone and are available in a variety of lengths and diameters to fit patient anatomy. The system components are made from medical grade Titanium Alloy Ti-6AI-4V ELI (ASTM F136), 17-4 SS (ASTM F899), 465 SS (ASTM A564), and 6061 T6 Aluminum (ASTM B221 and B209).
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    K Number
    K171413
    Device Name
    HAVEN™ Laminoplasty System, CANOPY® Laminoplasty Fixation System
    Manufacturer
    Globus Medical Inc.
    Date Cleared
    2017-07-14

    (60 days)

    Product Code
    NQW, NOW
    Regulation Number
    888.3050
    Why did this record match?
    Product Code :

    NQW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HAVEN™ Laminoplasty System is intended for use in the lower cervical and upper thoracic spine (C3-T3) in laminoplasty procedures. The HAVEN™ Laminoplasty System is used to hold bone allograft material in place in order to prevent the graft from expulsion or impinging the spinal cord. The CANOPY® Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3-T3) in laminoplasty procedures. The CANOPY® Laminoplasty Fixation System is used to hold bone allograft or autograft material in place in order to prevent the graft from expulsion or impinging the spinal cord.
    Device Description
    The HAVEN™ Laminoplasty System consists of spinal fixation plates for use in Laminoplasty. These implants are composed of titanium or titanium alloy (per ASTM F67, F136, F1295, and F1472). HAVEN™ implants may be used with previously cleared CANOPY®, RELIEVE®, QUARTEX™, ELLIPSE®, PROTEX CT® screws and CANOPY® Spacer. The CANOPY® Laminoplasty Fixation System consists of spinal fixation plates and screws for use in laminoplasty procedures. CANOPY® implants are inserted through a posterior cervical or thoracic approach, and are available in various sizes and geometric options to fit individual patient anatomy. Fixation plates may be used with bone graft material. Hinge plates may be used to stabilize a weakened or displaced lamina. Screws are used to attach the plates to bone and are available in a variety of lengths and diameters to fit patient anatomy. CANOPY® plates and screws are manufactured from titanium or titanium alloy, as specified in ASTM F67, F136, F1295 and F1472. Optional graft chambers are manufactured from radiolucent PEEK as specified in ASTM F2026 and contain tantalum or titanium alloy markers to permit radiographic visualization, per ASTM F67, F136, F560, F1295 or F1472.
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