FDA 510(k)

AlignX Ankle Fusion System

K-Number: K181067 · 2018-05-23

Decision Date2018-05-23

Product CodeHRS

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

AlignX Ankle Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Extremity Medical, LLC. It received FDA 510(k) clearance on 2018-05-23 under 510(k) number K181067. 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 AlignX Ankle Fusion System?

AlignX Ankle Fusion System is a medical device that received FDA 510(k) clearance on 2018-05-23. The listed applicant is Extremity Medical, LLC. The 510(k) number is K181067.

When did AlignX Ankle Fusion System receive FDA 510(k) clearance?

AlignX Ankle Fusion System received FDA 510(k) clearance on 2018-05-23, under 510(k) number K181067.

Who is the listed applicant for AlignX Ankle Fusion System?

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

What is the FDA product code for AlignX Ankle Fusion System?

The FDA product code for AlignX Ankle Fusion System is HRS.

Other records listing Extremity Medical, 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.

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Related Devices (Code: HRS)

K260277MIKRON TRAUMA BONE PLATE& SCREW SYSTEMMikron Makina San. ve Tic. Ltd. Sti.K261511Xpert AnkleNewclip Technics K261406Versalock 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 Technics K261054RibPlate 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.