FDA 510(k)

Arsenal Plating System

K-Number: K191009 · 2019-08-12

Decision Date2019-08-12

Product CodeHRS

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Arsenal Plating System is a medical device manufactured by Trilliant Surgical. It received FDA 510(k) clearance on 2019-08-12 under approval number K191009. 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 Arsenal Plating System?

Arsenal Plating System is a medical device that received FDA 510(k) clearance on 2019-08-12. It is manufactured by Trilliant Surgical. The 510(k) number is K191009.

When was Arsenal Plating System approved by the FDA?

Arsenal Plating System received FDA 510(k) clearance on 2019-08-12, under approval number K191009.

What company makes Arsenal Plating System?

Arsenal Plating System is manufactured by Trilliant Surgical.

What is the FDA product code for Arsenal Plating System?

The FDA product code for Arsenal Plating System is HRS.

Other Devices by Trilliant Surgical

K172405SNIPER STAPLE SYSTEM, NON-STERILE K181898Two-Step Implant System K212378Arsenal Ankle Plating 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.