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510(k) Data Aggregation

    K Number
    K212220
    Device Name
    ArtFX Spinal Fixation System
    Manufacturer
    ArtFX Medical LLC
    Date Cleared
    2023-04-20

    (643 days)

    Product Code
    NKB, KWP, KWQ
    Regulation Number
    888.3070
    Why did this record match?
    Applicant Name (Manufacturer) :

    ArtFX Medical LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ARTFX SPINAL FIXATION SYSTEM is intended for use in the noncervical spine. When used as an anterior anterolateral and posterior, noncervical pedicle and non-pedicle fixation system, the ARTFX SPINAL FIXATION SYSTEM is intended to provide additional support during fusion using autograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: -Degenerative dise disease (DDD) (defined as back pain of discogenic origin with degeneration of the dise confirmed by history and radiographic studies): . -Spondylolisthesis; - Trauma (i.e. fi acture or dislocation); -Spinal stenosis: - -Curvatures (i.e. scoliosis, kyphosis, and/or lordosis) - Tumor: - -Pseudoarthrosis; and Failed previous fusion
    Device Description
    The Proposed system is a top-loading multiple component, posterior spinal fixation system consisting of polyaxial pedicle screws, monoaxial pedicle screws, cannulated screws , rods (Straight and pre-bent) , connectors , hooks and setscrews. The Artfx Spinal Fixation System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. ARTFX SPINAL FIXATION SYSTEM is supplied non-sterile, single use and fabricated from titanium alloy (Ti6Al4V-ELI) that conforms to ASTM F136.
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    K Number
    K211718
    Device Name
    Venus Cervical Plate System
    Manufacturer
    ArtFx Medical LLC
    Date Cleared
    2022-06-28

    (389 days)

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

    ArtFx Medical LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Venus Cervical Plate System is intervertebral screw fixation of the cervical spine at levels C2-T 1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications: -Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) -Trauma (including fractures) -Tumors -Deformities or curvatures (including kyphosis, lordosis, or scoliosis) -Pseudarthrosis -Failed previous fusion -Decompression of the spinal cord following total or partial cervical vertebrectomy -Spondylolisthesis -Spinal stenosis.
    Device Description
    The Venus Cervical Plate System is supplied non-sterile, single use and are fabricated from titanium alloy (Ti6Al4V-ELI) that conforms to ASTM F136. Various sizes of these components are available. The Venus Cervical Plate System configurations ranging in lengths from 17 mm to the one-level plates, 27 mm to 40 mm for the two-level plates, 45 mm for the three-level plates, , and 70 mm to 90 mm for the four -level plates. All of the plate levels incorporate blocking mechanism to aid in prevention of bone screw back-out. The bone screws are provided with fixed angles available in self- tapping design. The fixed bone screws are inserted at a defined angle. The bone screws are offered in 3.5 mm, 4.0 mm and 4.50 mm diameters in lengths of 12 mm – 22 mm. The implants (bone screws and cervical plates) are provided as single-use, non-sterile devices manufactured from implantable grade titanium alloy (TI6Al4V-ELI). The Venus Cervical Plate System is intended for use as an aid in cervical spinal fusion . The Venus Cervical Plate System is supplied non-sterile, single use and are fabricated from titanium alloy (Ti6Al4V-ELI) that conforms to ASTM F136. Various sizes of these components are available.
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