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FDA 510(k)

EPIC Extremity Fusion Plate System

K-Number: K182991 · 2019-02-13

ApplicantEpic Extremity, LLC
Decision Date2019-02-13
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EPIC Extremity Fusion Plate System is a medical device manufactured by Epic Extremity, LLC. It received FDA 510(k) clearance on 2019-02-13 under approval number K182991. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EPIC Extremity Fusion Plate System?

EPIC Extremity Fusion Plate System is a medical device that received FDA 510(k) clearance on 2019-02-13. It is manufactured by Epic Extremity, LLC. The 510(k) number is K182991.

When was EPIC Extremity Fusion Plate System approved by the FDA?

EPIC Extremity Fusion Plate System received FDA 510(k) clearance on 2019-02-13, under approval number K182991.

What company makes EPIC Extremity Fusion Plate System?

EPIC Extremity Fusion Plate System is manufactured by Epic Extremity, LLC.

What is the FDA product code for EPIC Extremity Fusion Plate System?

The FDA product code for EPIC Extremity Fusion Plate System is HRS.

Related Clinical Trials

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Other Devices by Epic Extremity, LLC

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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.

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