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510(k) Data Aggregation
(183 days)
The Sync Cervical Interbody Fusion System is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
The Sync VBR Fusion System is a vertebral body replacement system indicated for use in skeletally mature patients to replace a collapsed, damaged, diseased, or unstable vertebral body due to tumor or trauma (i.e. fracture) or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues. The device is intended for use in the cervical spine (from C3 to C7) and in the thoracolumbar spine (from T1-L5). The device is intended for use with supplemental fixation cleared by the FDA for use in the cervical, thoracic, or lumbar spine and is to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft.
The Sync Cervical Interbody Fusion System is an anterior interbody fusion device for use in the cervical spine (C2-T1). The Sync VBR Fusion System is a vertebral body replacement device for use in the cervical and thoracic spine. Interbody and VBR Fusion components are available in a variety of heights and footprints to suit the individual pathology and anatomy of the patient. The device components are made from titanium alloy (Ti-6Al-4V) conforming to ASTM F136 or PEEK conforming to ASTM F2026. The PEEK interbody fusion device components have tantalum marker pins manufactured from tantalum per ASTM F560 for radiographic visualization.
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