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510(k) Data Aggregation
K Number
K201676Device Name
Barricaid Instrument Tray
Manufacturer
Date Cleared
2020-07-16
(27 days)
Regulation Number
888.4510Why did this record match?
Product Code :
QHG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Intrinsic Therapeutics Defect Measurement Tool for the Barricaid® Annular Closure Device is intended to aid in determining if a patient meets the indications for the Barricaid® Annular Closure Device by assessing the defect size in the annulus fibrosus following limited discectory. This tool is indicated to only be used with the Intrinsic Therapeutics Barricaid® Annular Closure Device.
Device Description
The Barricaid® Instrument kit contains a number of manual surgical instruments as well as the Defect Measurement Tool. This kit is provided with all of the instruments with a sterilization tray. The Defect Measurement Tool is intended to measure the annular defect to determine if a patient meets the indications for use for the Barricaid® Annular Closure Device. All instruments are made from stainless steel. This kit is intended to be used only with the Intrinsic Therapeutics Barricaid® Annular Closure Device (ACD).
The purpose of this submission is to modify and reduce the size of the sterilization tray used to contain the reusable instruments necessary to surgically implant or remove the Barricaid® Annular closure device.
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