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FDA 510(k)

TriMed Ankle Fixation System

K-Number: K243999 · 2025-03-19

ApplicantTriMed, Inc.
Decision Date2025-03-19
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TriMed Ankle Fixation System is a medical device manufactured by TriMed, Inc.. It received FDA 510(k) clearance on 2025-03-19 under approval number K243999. 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 TriMed Ankle Fixation System?

TriMed Ankle Fixation System is a medical device that received FDA 510(k) clearance on 2025-03-19. It is manufactured by TriMed, Inc.. The 510(k) number is K243999.

When was TriMed Ankle Fixation System approved by the FDA?

TriMed Ankle Fixation System received FDA 510(k) clearance on 2025-03-19, under approval number K243999.

What company makes TriMed Ankle Fixation System?

TriMed Ankle Fixation System is manufactured by TriMed, Inc..

What is the FDA product code for TriMed Ankle Fixation System?

The FDA product code for TriMed Ankle Fixation System is HRS.

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Other Devices by TriMed, Inc.

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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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