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FDA 510(k)

Arthrex Humeral Plating System and Cerclage Button

K-Number: K243995 · 2025-03-26

ApplicantArthrex, Inc.
Decision Date2025-03-26
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex Humeral Plating System and Cerclage Button is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2025-03-26 under approval number K243995. 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 Humeral Plating System and Cerclage Button?

Arthrex Humeral Plating System and Cerclage Button is a medical device that received FDA 510(k) clearance on 2025-03-26. It is manufactured by Arthrex, Inc.. The 510(k) number is K243995.

When was Arthrex Humeral Plating System and Cerclage Button approved by the FDA?

Arthrex Humeral Plating System and Cerclage Button received FDA 510(k) clearance on 2025-03-26, under approval number K243995.

What company makes Arthrex Humeral Plating System and Cerclage Button?

Arthrex Humeral Plating System and Cerclage Button is manufactured by Arthrex, Inc..

What is the FDA product code for Arthrex Humeral Plating System and Cerclage Button?

The FDA product code for Arthrex Humeral Plating System and Cerclage Button is HRS.

Related Clinical Trials

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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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