ExsoMed ITN Cannulated Screw System
K-Number: K171558 · 2017-09-01
ApplicantExsomed Holdings Company, LLC
Decision Date2017-09-01
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
ExsoMed ITN Cannulated Screw System is a medical device manufactured by Exsomed Holdings Company, LLC. It received FDA 510(k) clearance on 2017-09-01 under approval number K171558. 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 ExsoMed ITN Cannulated Screw System?
ExsoMed ITN Cannulated Screw System is a medical device that received FDA 510(k) clearance on 2017-09-01. It is manufactured by Exsomed Holdings Company, LLC. The 510(k) number is K171558.
When was ExsoMed ITN Cannulated Screw System approved by the FDA?
ExsoMed ITN Cannulated Screw System received FDA 510(k) clearance on 2017-09-01, under approval number K171558.
What company makes ExsoMed ITN Cannulated Screw System?
ExsoMed ITN Cannulated Screw System is manufactured by Exsomed Holdings Company, LLC.
What is the FDA product code for ExsoMed ITN Cannulated Screw System?
The FDA product code for ExsoMed ITN Cannulated Screw System is HWC. This falls under the Cardiovascular category.
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Official Source
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