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510(k) Data Aggregation
K Number
K141557Device Name
HERNIATOME PERCUTANEOUS DISECTOMY DEVICE - CERVICAL, HERNIATOME PERCUTANEOUS DISECTOMY DEVICE - LUMBAR
Manufacturer
GALLINI MEDICAL DEVICES, SRL
Date Cleared
2014-12-08
(179 days)
Product Code
HRX
Regulation Number
888.1100Why did this record match?
Applicant Name (Manufacturer) :
GALLINI MEDICAL DEVICES, SRL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Herniatome Percutaneous Discectomy Device is intended for use in aspiration of disc material during percutaneous discectomies in the lumbar, thoracic, and cervical regions of the spine.
Device Description
The Herniatome Percutaneous Discectomy Kit is comprised of an Introducer needle and a Herniatome Percutaneous Discectomy Device. The Herniatome Percutaneous Discectomy Device is a single-use disposable discectomy device that is designed to remove intervertebral disc nucleus pulpous material under CT and fluoroscopic guidance. Radiopaque marker bands are located on the Introducer needle and the Herniatome Percutaneous Discectomy Device. The Herniatome Percutaneous Discectomy Device contains a battery source DC motor that causes the internal double pitch mechanism to act as a screw conveyor to retrieve and remove the excised debris through the outer cannula and into the transparent collection container.
The Herniatome Percutaneous Discectomy Device is provided in two base models, a curved or straight distal end cannula with a lateral window and each model is provided with two different gage cannulas and two different cannula lengths for utilization in the specific region of the spine.
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