Search Filters

Search Results

Found 4 results

510(k) Data Aggregation

    K Number
    K240505
    Device Name
    Eminent Spine SI Screw System
    Manufacturer
    Eminent Spine, LLC
    Date Cleared
    2024-06-04

    (104 days)

    Product Code
    OUR
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    Eminent Spine, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Eminent Spine Sl Screw System is intended for sacroiliac joint fusion for conditions including degenerative sacroillitis and sacroiliac joint disruptions, to augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion and acute, non-acute, and non-traumatic fractures involving the sacroiliac joint. This includes those whose symptoms began during pregnancy or in the period and have persisted postpartum for more than 6 months.
    Device Description
    The Eminent Spine Sacroiliac (SI) Screw System is intended for sacroiliac joint fixation for conditions including degenerative sacroiliac joint disruption. The Eminent Spine SI Screw System consists of screws manufactured from Ti-6Al-4V ELI per ASTM F136 using traditional machining methods, as well as 3D-printed titanium alloy Ti-6AI-4V ELI per ASTM F3001. The screws are available in a variety of lengths and diameters to accommodate varying patient anatomy. The cannulated screws have open and porous graft windows for the Ø8.5, Ø10.0, Ø11.5, and Ø13.0mm options to allow bone growth through the implant. Optional locking crowns/locking fangs are included for all of the available screw diameters to aid in conforming to patient anatomy.
    Ask a Question
    K Number
    K230219
    Device Name
    Eminent Spine 3D Lumbar Interbody Fusion Systems
    Manufacturer
    Eminent Spine, LLC
    Date Cleared
    2023-05-16

    (110 days)

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

    Eminent Spine, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Eminent Spine 3D Lumbar Interbody Fusion Systems (PLIF, and ALIF) are indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and autograft to facilitate fusion. Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation.
    Device Description
    The Eminent Spine 3D Lumbar Interbody Fusion Systems are intervertebral body fusion systems used in the spine to replace a collapsed, damaged, or unstable disc. The 3D Lumbar Interbody Fusion Systems (PLIF, TLIF, and ALIF) are comprised of various sizes and configurations to accommodate individual patient anatomy. The configurations are designed to provide the surgeon with different surgical approach options, and packed with autogenous bone graft to facilitate fusion. Serrations on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebral bodies to aid in expulsion resistance. The device is intended to provide mechanical support to the implanted level until biologic fusion is achieved.
    Ask a Question
    K Number
    K212853
    Device Name
    Cervical Stand-Alone System
    Manufacturer
    Eminent Spine, LLC
    Date Cleared
    2021-11-05

    (59 days)

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

    Eminent Spine, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cervical Stand-Alone System is a stand-alone anterior cervical interbody fusion system indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one or two contiguous disc levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The Cervical Stand-Alone System is used to facilitate intervertebral body fusion in the cervical spine and is placed via an anterior approach at one- or two-disc levels (C2-T1) using autograft bone. Patients should have at least six (6) weeks of non-operative treatment prior to treatment. The Cervical Stand-Alone Interbody Fusion System is intended to be used with the bone screw fixation provided and requires no additional fixation.
    Device Description
    The Cervical Stand-Alone System implants are available in various heights and geometric footprints to accommodate individual patient anatomy and graft material size. Cervical Stand-Alone devices are inserted through an anterior cervical approach and packed with autogenous bone graft to facilitate fusion. Serrations on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebral bodies to aid in expulsion resistance, while screws are inserted through the anterior face of the implant for bone fixation. The device is intended to provide mechanical support to the implanted level until biologic fusion is achieved. The cages are made from medical grade polyetheretherketone (PEEK) per ASTM F2026 with tantalum per ASTM F560 pins, from titanium alloy Ti-6A1-4V ELI per ASTM F136, or from additively manufactured Ti-6Al-4V per ASTM F3001. The integrated fixation screws and screw anti-backout plate are manufactured from Ti-6A1-4V ELI per ASTM F136. These devices are offered non-sterile.
    Ask a Question
    K Number
    K201979
    Device Name
    Cervical Plate System
    Manufacturer
    Eminent Spine, LLC
    Date Cleared
    2020-08-25

    (40 days)

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

    Eminent Spine, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7) as an adjunct to fusion. These implants have been designed to provide stabilization for the treatment of the following indications: 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., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, or scoliosis), tumor, pseudarthrosis or failed previous fusion.
    Device Description
    The Cervical Plate System is an anterior cervical plating system that consists of plates and selftapping screws. The implants are available in a variety of shapes to accommodate the anatomical condition of patients. The subject device components are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136.
    Ask a Question

    Page 1 of 1