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510(k) Data Aggregation
K Number
K050588Device Name
VERTEVIEW ANTERIOR CERVICAL PLATE SYSTEM
Manufacturer
INNOVATIVE SPINAL DESIGN, LLC
Date Cleared
2005-04-21
(44 days)
Product Code
KWQ
Regulation Number
888.3060Why did this record match?
Applicant Name (Manufacturer) :
INNOVATIVE SPINAL DESIGN, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma (i.e., fractures or dislocation), 3) tumors, 4) spinal stenosis, 5) spondylolisthesis, 6)deformity or curvatures (i.e., kyphosis and/or lordosis, or scoliosis), 7) pseudoarthrosis, and/or 8) failed previous fusions.
Device Description
The Verteview Anterior Cervical Plate System is a fixation device consisting of a variety of sizes of cervical plates, locking tabs, fixed and variable angle bone screws, and associated instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. The screws have various diameters. All components are supplied clean not sterile.
The Verteview Anterior Cervical Plate System implant components are made from titanium alloy Ti-6Al-4V ELI and are surface treated with titanium anodization per AMS (Aerospace Material Specification) 2488 Type II. Bone screws are subjected to a color anodizing process to differentiate the screw type and diameter.
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