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510(k) Data Aggregation
K Number
K092011Device Name
NORM SPINAL SYSTEM
Manufacturer
NORM TIBBI URUNLER ITHALAT IHRACAT SANAYI VE TICAR
Date Cleared
2009-10-28
(114 days)
Product Code
MNH, MNI
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
NORM TIBBI URUNLER ITHALAT IHRACAT SANAYI VE TICAR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
NORM spinal system implants are designed to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following indications 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).
Levels of fixation are for the thoracic, lumbar and sacral spine.
Norm Posterior Spinal System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogeneous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attachment of a solid fusion.
Device Description
Norm Spinal System is a top-loading multiple component, posterior spinal fixation system consisting of polyaxial pedicle screws, rods and set screw. The Norm Spinal 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 Norm Spinal System components are supplied non-sterile, single use and fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136. Various sizes of these components are available.
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