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510(k) Data Aggregation
K Number
K071151Device Name
TENSION BAND ANTERIOR SPINAL SYSTEM
Date Cleared
2007-11-07
(196 days)
Product Code
Regulation Number
888.3060Why did this record match?
Applicant Name (Manufacturer) :
SPINAL INSTRUMENTATION SIMPLIFICATION SYSTEMS LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Tension Band Anterior Spinal System is intended for unilateral screw fixation of the anterolateral thoracolumbar spine from T7 to L5. The TBA Spinal System is intended to provide stabilization of a spinal segment(s) as an adjunct to spinal fusion. Indications for the use of this device include trauma, spinal stenosis, deformities or curvatures (e.g., scoliosis, kyphosis and/or lordosis), tumor, pseudarthrosis, failed fusion or degenerative disc disease (DDD) defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
Device Description
The Tension Band Anterior (TBA) Spinal System includes rods, hooks, wedges, and bone (vertebral) and lockdown screws. A single rod diameter and a range of hook sizes with size-matched bone screws are available. Wedges and lockdown screws serve as the interconnection mechanism.
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