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FDA 510(k)

Arthrex Elbow Fracture Plating System

K-Number: K242079 · 2024-11-14

ApplicantArthrex, Inc.
Decision Date2024-11-14
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex Elbow Fracture Plating System is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2024-11-14 under approval number K242079. 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 Arthrex Elbow Fracture Plating System?

Arthrex Elbow Fracture Plating System is a medical device that received FDA 510(k) clearance on 2024-11-14. It is manufactured by Arthrex, Inc.. The 510(k) number is K242079.

When was Arthrex Elbow Fracture Plating System approved by the FDA?

Arthrex Elbow Fracture Plating System received FDA 510(k) clearance on 2024-11-14, under approval number K242079.

What company makes Arthrex Elbow Fracture Plating System?

Arthrex Elbow Fracture Plating System is manufactured by Arthrex, Inc..

What is the FDA product code for Arthrex Elbow Fracture Plating System?

The FDA product code for Arthrex Elbow Fracture Plating System is HRS.

Related Clinical Trials

NCT03487250 Percutaneous US Guided Elbow Tenotomy With the TenJet HydroSurgery System COMPLETED NCT07520851 Efficacy of the Buzzy System on Pain and Fear Reduction in Elbow Fracture Pin Removal RECRUITING NCT05773352 Perform® Humeral System - Fracture Study (PFX) ACTIVE_NOT_RECRUITING NCT06772142 Early Feasibility of the Nervonik Peripheral Nerve Stimulation Device RECRUITING NCT07511478 Fibula Plating vs Intramedullary K-Wire in Bimalleolar Ankle Fractures COMPLETED NCT07495254 Effectiveness of Combined Super Inductive System (SIS) Therapy With Therapeutic Exercise and Health Education in Lateral Elbow Tendinopathy NOT_YET_RECRUITING

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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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