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FDA 510(k)

Epic Extremity Plate System

K-Number: K153340 · 2016-02-09

ApplicantEpic Extremity, LLC
Decision Date2016-02-09
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Epic Extremity Plate System is a medical device manufactured by Epic Extremity, LLC. It received FDA 510(k) clearance on 2016-02-09 under approval number K153340. 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 Plate System?

Epic Extremity Plate System is a medical device that received FDA 510(k) clearance on 2016-02-09. It is manufactured by Epic Extremity, LLC. The 510(k) number is K153340.

When was Epic Extremity Plate System approved by the FDA?

Epic Extremity Plate System received FDA 510(k) clearance on 2016-02-09, under approval number K153340.

What company makes Epic Extremity Plate System?

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

What is the FDA product code for Epic Extremity Plate System?

The FDA product code for Epic Extremity Plate System is HRS.

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Other Devices by Epic Extremity, LLC

K153333Epic Extremity Cannulated Screw System K172441EPIC Extremity Fracture Plate System K163038EPIC Extremity Snap-Off Screw K182991EPIC Extremity Fusion Plate System

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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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