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FDA 510(k)

Align Anterior Ankle Fusion Plate

K-Number: K160191 · 2016-03-25

ApplicantExtremity Medical, LLC
Decision Date2016-03-25
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Align Anterior Ankle Fusion Plate 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 2016-03-25 under 510(k) number K160191. 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 Align Anterior Ankle Fusion Plate?

Align Anterior Ankle Fusion Plate is a medical device that received FDA 510(k) clearance on 2016-03-25. The listed applicant is Extremity Medical, LLC. The 510(k) number is K160191.

When did Align Anterior Ankle Fusion Plate receive FDA 510(k) clearance?

Align Anterior Ankle Fusion Plate received FDA 510(k) clearance on 2016-03-25, under 510(k) number K160191.

Who is the listed applicant for Align Anterior Ankle Fusion Plate?

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 Align Anterior Ankle Fusion Plate?

The FDA product code for Align Anterior Ankle Fusion Plate is HRS.

Related Clinical Trials

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.

NCT05762055Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative TechnologyENROLLING_BY_INVITATION

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.

K250536MetaFore Small Screw SystemK251128Extremity Medical External Fixation SystemK241563Extremity Medical External Fixation SystemK212297Omni Foot and Ankle Plating SystemK211261Axis Charcot Fixation SystemK201556Intraosseous Fixation System

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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

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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