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510(k) Data Aggregation
K Number
K203308Device Name
Ali Interbody Fusion System
Manufacturer
Date Cleared
2021-01-15
(66 days)
Product Code
Regulation Number
888.3080Why did this record match?
Applicant Name (Manufacturer) :
Raed M. Ali, M.D., Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Ali Interbody Fusion System is indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level or two contiguous levels from L1-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. The Ali Interbody Fusion System can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The Ali Interbody Fusion is to be used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft, and supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.
Device Description
The Ali Interbody Fusion System is used to provide structural stability and maintain disc space distraction during intervertebral body fusion in the lumbosacral spine. The Subject Device implants are fabricated from PEEK (ASTM F2026) or Titanium (ASTM F136) with Titanium endplates. The Ali Interbody Fusion System implants are available in a range of sizes and shapes, and are designed to accommodate variations in surqical approach and patient anatomy. Each cage assembly has a hollow center to allow placement of autograft and/or allograft. Fixation ridges on the superior and inferior endplates of the device help to grip the endplates and prevent expulsion.
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