EPIC Extremity Snap-Off Screw
K-Number: K163038 · 2017-02-28
ApplicantEpic Extremity, LLC
Decision Date2017-02-28
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
EPIC Extremity Snap-Off Screw is a medical device manufactured by Epic Extremity, LLC. It received FDA 510(k) clearance on 2017-02-28 under approval number K163038. 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 Snap-Off Screw?
EPIC Extremity Snap-Off Screw is a medical device that received FDA 510(k) clearance on 2017-02-28. It is manufactured by Epic Extremity, LLC. The 510(k) number is K163038.
When was EPIC Extremity Snap-Off Screw approved by the FDA?
EPIC Extremity Snap-Off Screw received FDA 510(k) clearance on 2017-02-28, under approval number K163038.
What company makes EPIC Extremity Snap-Off Screw?
EPIC Extremity Snap-Off Screw is manufactured by Epic Extremity, LLC.
What is the FDA product code for EPIC Extremity Snap-Off Screw?
The FDA product code for EPIC Extremity Snap-Off Screw 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.