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510(k) Data Aggregation
K Number
K130073Device Name
MIKRON SPINAL FIXATION SYSTEM, POLYXIAL PEDICLE SCREWS, SET SCREWS, LONGITUDINAL RODS
Manufacturer
MIKRON MAKINA SANAYI VE TICARET LTD STI
Date Cleared
2013-12-16
(339 days)
Product Code
MNI, MNH
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
MIKRON MAKINA SANAYI VE TICARET LTD STI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MSFX Pedicle Screw 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 (T1 to S2): severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; spinal stenosis; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).
Device Description
Mikron Spinal Fixation System is a top-loading multiple component, posterior spinal fixation system consisting of polyaxial pedicle screws, rods, and set screws. The Mikron Spinal Fixation System will allow surgeons to build a spinal implant construction to stabilize and promote spinal fusion and it functions to build a spinal implant construct to stabilize and promote spinal fusion. The Mikron Spinal Fixation System components are supplied non-sterile, single use and fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136-11. Various sizes of these components are available.
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