CrossRoads Screw System
K-Number: K191342 · 2019-08-19
ApplicantCrossroads Extemity Systems, LLC
Decision Date2019-08-19
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
CrossRoads Screw System is a medical device manufactured by Crossroads Extemity Systems, LLC. It received FDA 510(k) clearance on 2019-08-19 under approval number K191342. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the CrossRoads Screw System?
CrossRoads Screw System is a medical device that received FDA 510(k) clearance on 2019-08-19. It is manufactured by Crossroads Extemity Systems, LLC. The 510(k) number is K191342.
When was CrossRoads Screw System approved by the FDA?
CrossRoads Screw System received FDA 510(k) clearance on 2019-08-19, under approval number K191342.
What company makes CrossRoads Screw System?
CrossRoads Screw System is manufactured by Crossroads Extemity Systems, LLC.
What is the FDA product code for CrossRoads Screw System?
The FDA product code for CrossRoads Screw System is HWC. This falls under the Cardiovascular category.
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Official Source
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