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510(k) Data Aggregation
K Number
K101374Device Name
AAXTER A3 POSTERIOR SPINAL SYSTEM
Manufacturer
Date Cleared
2011-03-16
(303 days)
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
AAXTER CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Aaxter A3 Posterior Spinal System is intended for posterior pedicle and non-pedicle fixation in the non-cervical spine as an adjunct to fusion in skeletally mature patients for the following indication: spondylolisthesis (Grade 3 and 4), of the L5-S1 vertebra in skeletally-mature patients receiving fusion by autogenous bone graft having implants attainment to the lumbar and sacral spine with removal of implants after the attainment of a solid fusion.
In addition, the Aaxter A3 Posterior Spinal 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 of the vertebral body
· Dislocation
· Scoliosis
· Kyphosis
· Spinal tumor
Device Description
The Aaxter A3 Posterior Spinal System is a posterior spinal system which is a top loading multiple components, posterior pedicle and hook fixation system intended to provide segmental stabilization of spinal segments in skeletally mature patients as an adjunct to fusion.
The Aaxter A3 Posterior Spinal System consists of variety of rods, hooks, screws, and cross links used to build a spinal construct for stabilization and promotion of spinal fusion in the thoracic-lumbar and sacral regions.
The Aaxter A3 Posterior Spinal System implant system components are supplied non-sterile for single use and are made from medical titanium alloy (Ti-6Al-4V) that conforms to ASTM F136. Specialized instruments made from surgical grade stainless steel are used for all the operations of the Aaxter A3 Posterior Spinal System.
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