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510(k) Data Aggregation
K Number
K112429Device Name
GIZA(R) VERTEBRAL BODY REPLACEMENT
Manufacturer
EDEN SPINE, LLC
Date Cleared
2012-01-26
(156 days)
Product Code
MQP
Regulation Number
888.3060Why did this record match?
Applicant Name (Manufacturer) :
EDEN SPINE, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Giza® Vertebral Body Replacement is intended for use during open surgical procedures in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (e.g. fracture). The Giza® Vertebral Body Replacement is intended to be used with supplemental internal spinal fixation systems that have been labeled for use in the thoracic and lumbar spine (i.e. posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The use of allograft with the Giza® Vertebral Body Replacement device is optional.
Device Description
The Giza® is a thoracolumbar vertebral body replacement device. The Giza is comprised of a variety of implant sizes to accommodate various patients' anatomy and pathology, and associated instrumentation. The devices are available in three diameters, 14mm, 21mm and 27mm. The Giza® device can accommodate lordosis from 2-12 degrees and from18 mm to 90mm in height. . All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI).
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