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FDA 510(k)

Foot and Ankle System

K-Number: K200062 · 2021-02-22

ApplicantLeith Medical, LLC
Decision Date2021-02-22
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Foot and Ankle System is a medical device manufactured by Leith Medical, LLC. It received FDA 510(k) clearance on 2021-02-22 under approval number K200062. 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 Foot and Ankle System?

Foot and Ankle System is a medical device that received FDA 510(k) clearance on 2021-02-22. It is manufactured by Leith Medical, LLC. The 510(k) number is K200062.

When was Foot and Ankle System approved by the FDA?

Foot and Ankle System received FDA 510(k) clearance on 2021-02-22, under approval number K200062.

What company makes Foot and Ankle System?

Foot and Ankle System is manufactured by Leith Medical, LLC.

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

The FDA product code for Foot and Ankle 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 NCT07498166 Project Tendura: The Impact of Blood Flow Restriction Resistance Training (BFR-RT) in Patients With Achilles Tendon Rupture (ATR) Repair ACTIVE_NOT_RECRUITING NCT04594993 INFINITY™ With ADAPTIS™ Technology Study ACTIVE_NOT_RECRUITING

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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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