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510(k) Data Aggregation
K Number
K090303Device Name
XTEND-ST NUCLEUS REMOVAL SYSTEM, MODEL 9004
Manufacturer
Date Cleared
2009-04-30
(83 days)
Product Code
Regulation Number
888.1100Why did this record match?
Applicant Name (Manufacturer) :
CORESPINE TECHNOLOGIES, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The XTEND-ST Nucleus Removal System is intended to resect damaged or diseased nucleus pulposus material found in the adult lumbar disc space.
The XTEND-ST Nucleus Removal System is indicated to resect damaged or diseased intervertebral nucleus pulposus material found in the adult lumbar disc space.
Device Description
The CoreSpine XTEND-ST Nucleus Removal System is a soft tissue removal device that is comprised of a disposable, sterile handheid nucleus tissue cutting device, a table-top electronic control unit, and a foot pedal. The tip of the XTEND-ST cutting device can articulate and extend within the disc cavity providing an ability to reach areas of the disc that are otherwise unreachable with a rongeur. Cut tissue is continuously suctioned through a central lumen using a standard vacuum designed to minimize clogging. The XTEND-ST Nucleus Removal System is intended to effectively and efficiently prepare the disc space without damaging the annulus or endplates in preparation for a spinal implant or other therapy.
The XTEND-ST cutting device is made from a stainless steel rotary cutting mechanism with a motor housed in a plastic handle.
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