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510(k) Data Aggregation

    K Number
    K243191
    Device Name
    Atlas Spine Lateral Expandable Interbody System
    Manufacturer
    Atlas Spine, Inc.
    Date Cleared
    2024-11-26

    (57 days)

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

    Atlas Spine, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Atlas Spine Lateral Expandable Interbody System is indicated for spinal fusion procedures in skeletally mature patients at one or two contiquous levels in the thoracolumbar spine. Thoracic: T1-T2 to T11-T12, or at the thoracolumbar junction (T12-L1), following discectory for the treatment of a symptomatic degenerative disc disease (DDD), including thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain). Lumbar: L1-L2 to L5-S1. for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Atlas Spine Lateral Expandable Interbody System is intended for use on patients who have had at least six months of non-operative treatment. It is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine. Atlas Spine Lateral Expandable Interbody System spacers expanded greater than 20° must be used with the provided bone screws in addition to supplemental fixation.
    Device Description
    Not Found
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    K Number
    K202302
    Device Name
    Atlas Spine Rebar (Ti) Spacer System
    Manufacturer
    Atlas Spine, Inc.
    Date Cleared
    2020-10-30

    (77 days)

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

    Atlas Spine, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Atlas Spine Rebar® (Ti) Spacer System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The Atlas Spine Rebar® (Ti) Spacer System is intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The System is intended to be used with supplemental fixation. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
    Device Description
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    K Number
    K192570
    Device Name
    Atlas Spine Expandable Cervical Standalone Interbody System
    Manufacturer
    Atlas Spine, Inc.
    Date Cleared
    2020-02-28

    (163 days)

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

    Atlas Spine, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Atlas Spine Expandable Cervical Standalone Interbody System is a stand-alone anterior cervical interbody fusion system intended for use as an adjunct to fusion at one or two contiguous levels (C2-T1) in skeletally mature patients for the treatment of degenerative disc disease (defined as discogenic neck pain with degeneration of the disc confirmed by history and radiographic studies). These patients should have received at least six weeks of nonoperative treatment prior to treatment with the device. The Atlas Spine Expandable Cervical Standalone Interbody System is to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous bone and implanted via an open, anterior approach. The Atlas Spine Expandable Cervical Standalone Interbody System is intended to be used with the bone screw fixation provided by the V3 Segmental Plating system and requires no additional fixation.
    Device Description
    Atlas Spine Expandable Cervical Standalone Interbody System
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    K Number
    K182418
    Device Name
    V3 Segmental Plating System
    Manufacturer
    Atlas Spine, Inc.
    Date Cleared
    2018-11-29

    (85 days)

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

    Atlas Spine, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The V3 Segmental Plating System is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma (i.e., fractures or dislocation), 3) tumors, 4) spinal stenosis, 5) spondylolisthesis, 6) deformity or curvatures (i.e., kyphosis and/or lordosis, or scoliosis), 7) pseudoarthrosis, and/or 8) failed previous fusions.
    Device Description
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    K Number
    K180675
    Device Name
    Atlas Spine Expandable Cervical Interbody System
    Manufacturer
    Atlas Spine, Inc.
    Date Cleared
    2018-06-13

    (90 days)

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

    Atlas Spine, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Atlas Spine Expandable Cervical Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The Atlas Spine Expandable Cervical Interbody System is intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/or pain at multiple contiguous levels from C2 - T1. The System is intended to be used with supplemental fixation. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
    Device Description
    The Atlas Spine Expandable Cervical Interbody System consists of various size and style options to address the clinical and anatomic needs of individual patients. The implant is rectangular in its general shape with the capability to expand in height. The implant incorporates bone graft cavities through the superior and inferior surfaces to allow fusion between adjacent vertebral bodies. The implants incorporate a textured bone contacting surface to resist migration/expulsion of the implant post operatively. Additionally, the implant incorporates an opening posteriorly to allow the addition of bone graft post expansion. The implants components are manufactured from implantable grade Ti6AI4V per ASTM F136 alloy and Peek Optima LT1 delivered in the pre-assembled, unexpanded state.
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    K Number
    K172334
    Device Name
    Ortus™ Expandable Lumbar Interbody Fusion System
    Manufacturer
    Atlas Spine, Inc.
    Date Cleared
    2017-10-25

    (84 days)

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

    Atlas Spine, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ortus™ Expandable Lumbar Interbody Fusion System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved levels. These patients may have had a previous non-fusion surgery at the involved level(s). The Ortus™ Expandable Lumbar Interbody Fusion System is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft; and supplemental fixation system (i.e. Apelo Pedicle Screw System). Patients must have undergone a regimen of at least six months of non-operative treatment prior to being treated with the Ortus™ Expandable Lumbar Interbody Fusion System.
    Device Description
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    K Number
    K162918
    Device Name
    Atlas Spine Expandable Interbody System
    Manufacturer
    Atlas Spine, Inc.
    Date Cleared
    2017-02-09

    (114 days)

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

    Atlas Spine, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Atlas Spine Expandable Interbody System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved levels. These patients may have had a previous non-fusion surgery at the involved level(s). The Atlas Spine Expandable Interbody System is intended for use with autograft comprised of cancellous and/or corticocancellous bone graft; and supplemental fixation system (i.e. Firebird® Spinal Fixation System). Patients must have undergone a regimen of at least six months of non-operative treatment prior to being treated with the Atlas Spine Expandable Interbody System.
    Device Description
    The Atlas Spine Expandable Interbody System consists of various size and style options to address the clinical and anatomic needs of individual patients. The implant is rectangular in its general shape with the capability to expand in height infinitely within its design limitations. The implant incorporates bone graft cavities through the superior and inferior surfaces to allow fusion between adjacent vertebral bodies. The implants incorporate a textured bone contacting surface to resist migration/expulsion of the implant post operatively. Additionally, the implant incorporates an opening posteriorly to allow the addition of bone graft material post expansion. The implants components are manufactured from implantable grade Ti6Al4V alloy and Peek Optima LT1 delivered in the pre-assembled, unexpanded state.
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