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FDA 510(k)

EPIC Extremity Fracture Plate System

K-Number: K172441 · 2017-11-06

ApplicantEpic Extremity, LLC
Decision Date2017-11-06
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EPIC Extremity Fracture Plate System is a medical device manufactured by Epic Extremity, LLC. It received FDA 510(k) clearance on 2017-11-06 under approval number K172441. 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 Fracture Plate System?

EPIC Extremity Fracture Plate System is a medical device that received FDA 510(k) clearance on 2017-11-06. It is manufactured by Epic Extremity, LLC. The 510(k) number is K172441.

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

EPIC Extremity Fracture Plate System received FDA 510(k) clearance on 2017-11-06, under approval number K172441.

What company makes EPIC Extremity Fracture Plate System?

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

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

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

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Other Devices by Epic Extremity, LLC

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Related Devices (Code: HRS)

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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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