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510(k) Data Aggregation
K Number
K100956Device Name
SPONDY SPINAL FIXATION SYSTEM
Manufacturer
ALLURE SPINE L.L.C.
Date Cleared
2010-07-09
(93 days)
Product Code
MNH, CLA, MNI
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
ALLURE SPINE L.L.C.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Spondy™ Spinal Fixation System is a posterior, non-cervical pedicle fixation system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine including degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudoarthrosis and failed previous fusion.
In addition, when used as a pedicle screw fixation system, the Spondy Spinal Fixation System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra, who are receiving fusion by autogenous bone graft only having the device attached to the lumbar and sacral spine (levels are L3-sacrum/ilium), who are having the device removed after the attainment of a solid fusion.
Device Description
The Spondy Spinal Fixation System is a top-loading spinal fixation system consisting of polyaxial screws, set screws, rods, and cross connectors assembled to create a rigid spinal construct. It is intended to provide stabilization during the development of fusion utilizing a bone graft as well as aid in the surgical correction of various spinal deformities and pathologies in the thoracolumbosacral iliac portion of the spine. The titanium alloy, single-use components are provided clean and non-sterile. Various sizes of the implants (screws and rods) are available to accommodate individual patient anatomy.
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