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510(k) Data Aggregation
K Number
K113361Device Name
SECURIS SPINAL FIXATION
Manufacturer
Date Cleared
2012-04-03
(141 days)
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
CUMTOM SPINE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Securis Spinal Fixation system is intended for immobilization and stabilization of the thoraco-lumbar-sacral spine (T1-S1) as an adjunct to fusion in skeletally mature patients for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
Device Description
The subject Securis Spinal Fixation System consist of screws of various diameter and length, non-sterile, single use Cannulated Titanium (ASTM F136, Ti-6Al-4V) screws and set screws to be used in conjunction with 5.0 mm diameter Cobalt-Chrome-Molybdenum (CoCr, ASTM F1537) rods. The rods are provided in various lengths to form various configurations for the individual patients and surgical condition. Instruments and guide wires are made from various grades of stainless steel.
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