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510(k) Data Aggregation
K Number
K083894Device Name
ALIF SPINAL TRUSS INTERBODY FUSION DEVICE
Manufacturer
4-WEB SPINE, LLC
Date Cleared
2011-01-18
(750 days)
Product Code
MAX
Regulation Number
888.3080Why did this record match?
Applicant Name (Manufacturer) :
4-WEB SPINE, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ALIF Spinal Truss System (STS) Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the device must be used with supplemental fixation and must be used with autograft bone. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).
Device Description
The ALIF STS Interbody Fusion Device is a titanium implant that is designed to provide mechanical support to the lumbar spine while biologic fusion takes place. The device is an "open architecture" design consisting of trusses mathematically designed to provide maximum support with the greatest amount of open space throughout the implant for bone growth and fusion. The implant is made from Ti6Al4V alloy.
The device is available in three basic "footprint" sizes, small, medium and large. These sizes are available in zero degree lordosis and 8 degree lordosis and each of these in 8 heights ranging from 10mm to 17mm in 1mm increments.
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