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510(k) Data Aggregation
K Number
K051697Device Name
SELECTIVE-AXIS POSTERIOR NONCERVICAL PLATING SYSTEM
Manufacturer
Date Cleared
2005-09-21
(90 days)
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL DEVICE ADVISORY DEVELOPMENT GROUP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Selective-Axis Posterior Noncervical Plating System is intended for use as a posterior, noncervical (thoracic, lumbar and sacral), pedicle screw fixation system for the following indications: degenerative disc disease ("DDD") (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis. trauma (i.e., fracture or dislocation), spinal stenosis, tumor, pseudoarthrosis, and failed fusion.
Device Description
The Selective-Axis Posterior Noncervical Plating System ("Selective-Axis Plating System") is comprised of the following components: Selective-Axis anchor screw assemblies, connecting beam assemblies, and jam nuts. All of the components of the Selective-Axis Plating System are manufactured from Ti6Al4V-ELI titanium alloy per ASTM F136.
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