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510(k) Data Aggregation
K Number
K080537Device Name
L-VARLOCK
Manufacturer
KISCOMEDICA S.A.
Date Cleared
2008-06-30
(124 days)
Product Code
MAX
Regulation Number
888.3080Why did this record match?
Applicant Name (Manufacturer) :
KISCOMEDICA S.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The L-Varlock Lumbar Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s).
L-Varlock Lumbar implants are to be used with autogenous bone graft and implanted via an open posterior approach. L-Varlock Lumbar implant is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
Device Description
L-Varlock Lumbar Cage is implanted via a posterior approach and supplemented by posterior fixation. Two devices are used. Main features of the L-Varlock lumbar cage are:
- Different heights for accurate enlargement of the foramina .
- Different widths and lengths to achieve excellent stability at the instrumented level . while preserving the patient's anatomy.
- Large graft space to achieve good bony fusion .
- Large cortical interface to ensure a good bony fusion. .
- Toothed outer walls prevent implant back out. ●
- The rounded geometry of the anterior end of the cage avoids damage to the anterior vascular structures.
Materials:
L-Varlock lumbar Cages are manufactured from titanium alloy (Ti6Al4V-Eli, ASTM norm F136).
Function:
Lumbar interbody cages are one of the treatment options for low back pain.
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