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510(k) Data Aggregation
K Number
K151312Device Name
VerteLP Interbody Fusion Device
Manufacturer
Date Cleared
2016-01-13
(240 days)
Product Code
Regulation Number
888.3080Why did this record match?
Applicant Name (Manufacturer) :
VGI, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The VerteLP is indicated for use in skeletally mature patients with Degenerative Disc Discase (DDD) at one or two contiguous levels from L2-L5. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patients should have received 6 months of non-operative treatment with the devices. The device is intended to be used with supplemental fixation to the integrated fixation jaws, and must be used with autograft bone.
Device Description
The Vertel.P implant is an Intervertebral Body Fusion Device (IBFD) intended to be used in the lumbar spine via a lateral surgical approach. It is intended to stabilize a spinal segment to promote fusion between adjacent vertebral bodies. It also provides indirect decompression to relieve constricted nerve roots. Center apertures have been designed into the VerteLP implant for placement of bone graft to promote fusion through the center of the implant. The device has integrated fixation in the form of laterally- locking jaws to facilitate additional stability. VerteLP is available in a variety of sizes and shapes in order to better accommodate each patient's unique anatomy. The implant is made from Ti6Al4V alloy per ASTM F-136, Zeniva PEEK ZA-500 per ASTM F2026, UHMWPE per ASTM F648 and tantalum per ASTM F560. The devices are available in two widths, heights from 7-17mm and in both parallel and lordotic shapes to accommodate varied patient's anatomy.
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