Epic Extremity Cannulated Screw System
K-Number: K153333 · 2016-01-19
ApplicantEpic Extremity, LLC
Decision Date2016-01-19
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Epic Extremity Cannulated Screw System is a medical device manufactured by Epic Extremity, LLC. It received FDA 510(k) clearance on 2016-01-19 under approval number K153333. 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 Epic Extremity Cannulated Screw System?
Epic Extremity Cannulated Screw System is a medical device that received FDA 510(k) clearance on 2016-01-19. It is manufactured by Epic Extremity, LLC. The 510(k) number is K153333.
When was Epic Extremity Cannulated Screw System approved by the FDA?
Epic Extremity Cannulated Screw System received FDA 510(k) clearance on 2016-01-19, under approval number K153333.
What company makes Epic Extremity Cannulated Screw System?
Epic Extremity Cannulated Screw System is manufactured by Epic Extremity, LLC.
What is the FDA product code for Epic Extremity Cannulated Screw System?
The FDA product code for Epic Extremity Cannulated Screw System is HWC. This falls under the Cardiovascular category.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.