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510(k) Data Aggregation
K Number
K121786Device Name
DYMAXEON SPINE SYSTEM
Manufacturer
B2B SPINE PTY LTD
Date Cleared
2012-11-05
(140 days)
Product Code
NKB, MNH, MNI
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
B2B SPINE PTY LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Dymaxeon 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 thoracic, lumbar, and sacral/iliac spine (T1 - S1/Ileum): degenerative disc disease (defined as discogenic back pain with degeneration of disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
Device Description
The Dymaxeon Spine System is a posterior pedicle screw system manufactured from titanium alloy (Ti6Al4V ELI per ASTM F136) designed for temporary stabilization of the spine during the development of spinal fusion. The Dymaxeon Spine System is comprised of polyaxial pedicle screws, reduction screws, and rods. The Dymaxeon Spine System can be used for single or multiple level fixations. The pedicle screws are available in various lengths and diameters.
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