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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 the device name listed in this FDA 510(k) record. The listed applicant is Epic Extremity, LLC. It received FDA 510(k) clearance on 2019-02-13 under 510(k) 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. The listed applicant is Epic Extremity, LLC. The 510(k) number is K182991.

When did EPIC Extremity Fusion Plate System receive FDA 510(k) clearance?

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

Who is the listed applicant for EPIC Extremity Fusion Plate System?

The FDA 510(k) record lists Epic Extremity, LLC as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Epic Extremity, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K172441EPIC Extremity Fracture Plate SystemK163038EPIC Extremity Snap-Off ScrewK153340Epic Extremity Plate SystemK153333Epic Extremity Cannulated Screw System

Related Devices (Code: HRS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260277MIKRON TRAUMA BONE PLATE& SCREW SYSTEMMikron Makina San. ve Tic. Ltd. Sti.K261511Xpert AnkleNewclip TechnicsK261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB )TriMed, Inc.K261191Alians Elbow SNewclip TechnicsK261054RibPlate SystemStryker Leibinger GmbH & Co KG

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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