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FDA 510(k)

Arthrx Fracture Plates

K-Number: K213837 · 2022-05-02

ApplicantArthrex, Inc.
Decision Date2022-05-02
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrx Fracture Plates is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2022-05-02 under approval number K213837. 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 Arthrx Fracture Plates?

Arthrx Fracture Plates is a medical device that received FDA 510(k) clearance on 2022-05-02. It is manufactured by Arthrex, Inc.. The 510(k) number is K213837.

When was Arthrx Fracture Plates approved by the FDA?

Arthrx Fracture Plates received FDA 510(k) clearance on 2022-05-02, under approval number K213837.

What company makes Arthrx Fracture Plates?

Arthrx Fracture Plates is manufactured by Arthrex, Inc..

What is the FDA product code for Arthrx Fracture Plates?

The FDA product code for Arthrx Fracture Plates is HRS.

Related Clinical Trials

NCT07520227 Comparative Evaluation of 3D-printed (PEEK) Plates Versus Titanium 3D Plate for Fracture Fixation at the Mandibular Angle COMPLETED

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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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