FDA 510(k)

TriLEAP Plating System

K-Number: K230591 · 2023-09-29

Decision Date2023-09-29

Product CodeHRS

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

TriLEAP Plating System is a medical device manufactured by Crossroads Extremity Systems. It received FDA 510(k) clearance on 2023-09-29 under approval number K230591. 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 TriLEAP Plating System?

TriLEAP Plating System is a medical device that received FDA 510(k) clearance on 2023-09-29. It is manufactured by Crossroads Extremity Systems. The 510(k) number is K230591.

When was TriLEAP Plating System approved by the FDA?

TriLEAP Plating System received FDA 510(k) clearance on 2023-09-29, under approval number K230591.

What company makes TriLEAP Plating System?

TriLEAP Plating System is manufactured by Crossroads Extremity Systems.

What is the FDA product code for TriLEAP Plating System?

The FDA product code for TriLEAP Plating System is HRS.

Other Devices by Crossroads Extremity Systems

K241050CrossRoads Modular Tray System K253178TRILEAP 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.