Search Filters

Search Results

Found 6 results

510(k) Data Aggregation

    K Number
    K240737
    Device Name
    G Surgical Marksman MIS System
    Manufacturer
    Date Cleared
    2024-04-05

    (18 days)

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

    G Surgical LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The G Surgical Marksman MIS System is intended to provide immobilization of the posterior noncervical spine (T1-S2/llium) in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis and/or lordosis), tumor, pseudarthrosis, and/or failed previous fusion. The G Surgical Marksman MIS System can be used in an open approach or a percutaneous approach with MIS instrumentation.
    Device Description
    The G Surgical Marksman MIS System consists of longitudinal members (rods), anchors (screws) and fasteners in a variety of sizes to accommodate differing anatomic requirements. The devices are sold nonsterile.
    Ask a Question

    Ask a specific question about this device

    K Number
    K230063
    Device Name
    G Surgical Marksman Spinal Deformity System
    Manufacturer
    Date Cleared
    2023-02-09

    (31 days)

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

    G Surgical LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The G Surgical Marksman Spinal Deformity System is intended to provide immobilization of the posterior non-cervical spine (T1-S2/Ilium) in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis and/or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.
    Device Description
    The G Surgical Marksman Spinal Deformity System consists of longitudinal members (rods), anchors (screws), connectors (crosslinks) and fasteners in a variety of sizes to accommodate differing anatomic requirements.
    Ask a Question

    Ask a specific question about this device

    K Number
    K210890
    Device Name
    GPS Cervical Spacers
    Manufacturer
    Date Cleared
    2021-04-23

    (29 days)

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

    G Surgical LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The GPS™ Cervical Spacers are indicated for use at multiple contiguous levels, from C2-T1, in skeletally mature patients who have had six weeks of non-operative treatment. The device is intended to treat cervical disc degeneration and/or cervical spinal instability as confirmed by imaging studies (radiographs, CT, MRI) that results in radiculopathy, myelopathy and/or pain. The device is to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and in combination with supplemental fixation cleared for use in the cervical spine.
    Device Description
    The basic shape of the GPS™ Cervical Spacers is a structural column having upper and lower implant openings and a central cavity for autograft bone. The devices have a have a "B" shaped cross-section. Surface teeth assist in the seating the implant between the vertebral bodies. Devices are available in a variety of size and angulation combinations to accommodate the diversity in patient anatomy.
    Ask a Question

    Ask a specific question about this device

    K Number
    K193219
    Device Name
    G Surgical Marksman System
    Manufacturer
    Date Cleared
    2019-12-17

    (26 days)

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

    G Surgical LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The G Surgical Marksman System is intended to provide immobilization of the posterior non-cervical spine (T1-S2/Ilium) in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis and/or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.
    Device Description
    The G Surgical Marksman MIS System consists of longitudinal members (rods), anchors (screws), connectors (crosslinks) and fasteners in a variety of sizes to accommodate differing anatomic requirements.
    Ask a Question

    Ask a specific question about this device

    K Number
    K171834
    Device Name
    G Surgical OCT Spinal System
    Manufacturer
    Date Cleared
    2017-12-19

    (182 days)

    Product Code
    Regulation Number
    888.3075
    Why did this record match?
    Applicant Name (Manufacturer) :

    G Surgical LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The G Surgical OCT Spinal System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, cervical spine (C1 to C7) and the thoracic spine (T1 to T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The G Surgical OCT Spinal System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. In order to achieve additional levels of fixation, the G Surgical OCT Spinal System may be connected to the G Surgical Pedicle System (GPS™) using 3.5mm/6.0mm axial connectors, domino connectors and transition rods.
    Device Description
    G Surgical OCT Spinal System consists of longitudinal members, anchors, interconnecting devices and fasteners in a variety of sizes to accommodate differing anatomic requirements. The implants are sold non-sterile.
    Ask a Question

    Ask a specific question about this device

    K Number
    K161516
    Device Name
    G Surgical Marksman MIS System
    Manufacturer
    Date Cleared
    2016-08-25

    (84 days)

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

    G SURGICAL LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The G Surgical Marksman MIS System is intended to provide immobilization of the posterior non-cervical spine (T1-S2/Ilium) in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, kyphosis and/or lordosis), tumor, pseudarthrosis, and/or failed previous fusion. The G Surgical Marksman MIS System can be used in an open approach or a percutaneous approach with MIS instrumentation.
    Device Description
    The G Surgical Marksman MIS System consists of longitudinal members (rods), anchors (screws) and fasteners in a variety of sizes to accommodate differing anatomic requirements.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1