Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

AlignX Ankle Fusion System

K-Number: K181067 · 2018-05-23

ApplicantExtremity Medical, LLC
Decision Date2018-05-23
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AlignX Ankle Fusion System is a medical device manufactured by Extremity Medical, LLC. It received FDA 510(k) clearance on 2018-05-23 under approval 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. It is manufactured by Extremity Medical, LLC. The 510(k) number is K181067.

When was AlignX Ankle Fusion System approved by the FDA?

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

What company makes AlignX Ankle Fusion System?

AlignX Ankle Fusion System is manufactured by Extremity Medical, LLC.

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

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

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07589829 The Effects of Kinesio Taping on Hallux Valgus COMPLETED NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT07556198 Effects of Whole-Body Vibration With Foot Core Exercises: A Randomized Controlled Trial COMPLETED NCT03965143 Talus Replacement Registry RECRUITING NCT04305925 Focal Laser Ablation of Prostate Cancer COMPLETED

Other Devices by Extremity Medical, LLC

K160191Align Anterior Ankle Fusion Plate K172260Omni Foot Plating System K171018Axis Charcot Fixation System, 4.5 to 8.5mm Screw System K180808Omni Foot Plating System K192592Axis Plating System K201556Intraosseous Fixation System

View all 13 devices →

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.

↑