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510(k) Data Aggregation
K Number
K180437Device Name
Hexanium® TLIF
Manufacturer
SpineVision, SAS
Date Cleared
2018-05-04
(73 days)
Product Code
MAX
Regulation Number
888.3080Why did this record match?
Applicant Name (Manufacturer) :
SpineVision, SAS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Hexanium® TLIF (Transformational Lumbar Interbody Fusion) system is an intervertebral body fusion device indicated for use with autogenous bone graft in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two continuous levels from L2-S1. 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 at least 6 months of non-operative treatment prior to treatment with Hexanium® TLIF system. This device has to be filled with autogenous bone graft material. This device is implanted via transforaminal approach. Hexanium® TLIF system must be used in combination with supplemental internal spinal fixation which has been cleared by the FDA for use in the lumbar spine.
Device Description
The Hexanium® TLIF device is a titanium alloy (Ti6Al4V ELI) interbody cage manufactured via an Additive Manufacturing method. The honeycomb structure allows for bone through-growth through the structure of the device as well as providing lateral and vertical bone graft windows in the body of the cage. Hexanium® TLIF is available in heights of 7mm to 16mm in 1mm increments in a Small footprint (28mm X 9mm) or a Medium footprint (32mm X 10.5mm). Hexanium® TLIF has a 5° Lordosis angle. Hexanium® TLIF devices are provided sterile.
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