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510(k) Data Aggregation
K Number
K111995Device Name
XINGTM SPINE SYSTEM
Manufacturer
Date Cleared
2011-12-12
(152 days)
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
IMPLANOVA CO. LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Xing™ Spine System is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
In addition, the Xing™ Spine System is 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: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).
Device Description
The Xing™ Spine System is a top-loading multiple component, posterior spinal fixation system which consists of pedicle screws, rods, set screws, and a cross link linking mechanism. The Xing™ Spine System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. Xing™ System implant components are supplied non-sterile are single use and are fabricated from titanium alloy (Ti-6A1-4V ELI) that conforms to ASTM F136. Various sizes of these implants are available. Specialized instruments are available for the application and removal of the Xing™ Spine System.
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