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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 a medical device manufactured by Extremity Medical, LLC. It received FDA 510(k) clearance on 2016-03-25 under approval 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. It is manufactured by Extremity Medical, LLC. The 510(k) number is K160191.

When was Align Anterior Ankle Fusion Plate approved by the FDA?

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

What company makes Align Anterior Ankle Fusion Plate?

Align Anterior Ankle Fusion Plate is manufactured by Extremity Medical, LLC.

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

NCT06462729 LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF) RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT06938607 Post-operative Outcomes of Anterior Cervical Discectomy and Fusion Surgery With and Without Drain Placement NOT_YET_RECRUITING NCT03965143 Talus Replacement Registry RECRUITING NCT06638138 Study of Artelon FLEXBAND® for Patients Undergoing Soft Tissue Reconstruction of the Anterior Talofibular Ligament (ATFL) to Treat Lateral Ankle Instability COMPLETED NCT04214535 Anterior Cervical Disectomy And Fusion Using The Tritanium® C Anterior Cervical Cage For One Or Two-Levels ACTIVE_NOT_RECRUITING

Other Devices by Extremity Medical, LLC

K172260Omni Foot Plating System K171018Axis Charcot Fixation System, 4.5 to 8.5mm Screw System K181067AlignX Ankle Fusion System K180808Omni Foot Plating System K192592Axis Plating System K201556Intraosseous Fixation System

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Related Devices (Code: HRS)

K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc. K162829Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc. K162974Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation K163007Biomet Microfixation SternaLock 360 Sternal Closure SystemBiomet Microfixation K161696aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5Aap Implantate AG K161747LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5; LOQTEQ® VA Distal Anterolateral Tibia Plate 3.5; LOQTEQ® VA Distal Fibula Plate 2.7/3.5Aap Implantate AG

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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