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510(k) Data Aggregation
K Number
K143258Device Name
PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)
Manufacturer
4WEB,INC.
Date Cleared
2015-04-09
(147 days)
Product Code
MAX
Regulation Number
888.3080Why did this record match?
Applicant Name (Manufacturer) :
4WEB,INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PLIF STS, TLIF STS and OLIF STS (Spine Truss System) are 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 devices. 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 4WEB PLIF STS, TLIF STS and OLIF STS (Spine Truss System) consists of a series of titanium implants that are designed to provide mechanical support to the spine while biologic fusion occurs. 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 multiple sizes to accommodate varied patient's anatomy.
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