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FDA 510(k)

TRUEMED HAND, FOOT AND ANKLE PLATES SYSTEM

K-Number: K200575 · 2021-07-09

ApplicantTruemed Group, LLC
Decision Date2021-07-09
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TRUEMED HAND, FOOT AND ANKLE PLATES SYSTEM is a medical device manufactured by Truemed Group, LLC. It received FDA 510(k) clearance on 2021-07-09 under approval number K200575. 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 TRUEMED HAND, FOOT AND ANKLE PLATES SYSTEM?

TRUEMED HAND, FOOT AND ANKLE PLATES SYSTEM is a medical device that received FDA 510(k) clearance on 2021-07-09. It is manufactured by Truemed Group, LLC. The 510(k) number is K200575.

When was TRUEMED HAND, FOOT AND ANKLE PLATES SYSTEM approved by the FDA?

TRUEMED HAND, FOOT AND ANKLE PLATES SYSTEM received FDA 510(k) clearance on 2021-07-09, under approval number K200575.

What company makes TRUEMED HAND, FOOT AND ANKLE PLATES SYSTEM?

TRUEMED HAND, FOOT AND ANKLE PLATES SYSTEM is manufactured by Truemed Group, LLC.

What is the FDA product code for TRUEMED HAND, FOOT AND ANKLE PLATES SYSTEM?

The FDA product code for TRUEMED HAND, FOOT AND ANKLE PLATES 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

Other Devices by Truemed Group, LLC

K162507Arzzt 3.5 / 4.5 Small & Large Fragments System K172189Ins Hilden Humeral Arzzt, Ins Hilden Cannulated Tibial Arzzt, Ins Hilden Femoral Arzzt & Ins Hilden Retrograde Femoral Arzzt K182650Arzzt Distal Radius and Ulna System

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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