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510(k) Data Aggregation
K Number
K132310Device Name
ASCOT
Manufacturer
Date Cleared
2013-12-23
(151 days)
Product Code
Regulation Number
888.3060Why did this record match?
Applicant Name (Manufacturer) :
BACKROADS CONSULTING, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
ASCOT® is intended for anterior cervical fixation (C2-C7) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis and/or lordosis), tumor, pseudarthrosis and failed previous fusion.
Device Description
ASCOT® is an anterior cervical plate and screw system. Plates offered in a variety of sizes to accommodate anatomic requirements. Fixed and variable angle screws are available in numerous length/diameter combinations. In addition, a center graft screw is offered.
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