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FDA 510(k)

Omni Foot and Ankle Plating System

K-Number: K212297 · 2021-08-20

ApplicantExtremity Medical, LLC
Decision Date2021-08-20
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Omni Foot and Ankle Plating System is a medical device manufactured by Extremity Medical, LLC. It received FDA 510(k) clearance on 2021-08-20 under approval number K212297. 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 Omni Foot and Ankle Plating System?

Omni Foot and Ankle Plating System is a medical device that received FDA 510(k) clearance on 2021-08-20. It is manufactured by Extremity Medical, LLC. The 510(k) number is K212297.

When was Omni Foot and Ankle Plating System approved by the FDA?

Omni Foot and Ankle Plating System received FDA 510(k) clearance on 2021-08-20, under approval number K212297.

What company makes Omni Foot and Ankle Plating System?

Omni Foot and Ankle Plating System is manufactured by Extremity Medical, LLC.

What is the FDA product code for Omni Foot and Ankle Plating System?

The FDA product code for Omni Foot and Ankle Plating System is HRS.

Related Clinical Trials

NCT07589829 The Effects of Kinesio Taping on Hallux Valgus COMPLETED NCT07556198 Effects of Whole-Body Vibration With Foot Core Exercises: A Randomized Controlled Trial COMPLETED NCT06941558 The UK ADAPTIS Study ACTIVE_NOT_RECRUITING NCT06638138 Study of Artelon FLEXBAND® for Patients Undergoing Soft Tissue Reconstruction of the Anterior Talofibular Ligament (ATFL) to Treat Lateral Ankle Instability COMPLETED NCT07511478 Fibula Plating vs Intramedullary K-Wire in Bimalleolar Ankle Fractures COMPLETED NCT07498166 Project Tendura: The Impact of Blood Flow Restriction Resistance Training (BFR-RT) in Patients With Achilles Tendon Rupture (ATR) Repair ACTIVE_NOT_RECRUITING

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 K181067AlignX Ankle Fusion System K180808Omni Foot Plating System K192592Axis Plating 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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