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FDA 510(k)

TriMed Posterior Malleolus Fixation System

K-Number: K243050 · 2024-11-26

ApplicantTriMed, Inc.
Decision Date2024-11-26
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TriMed Posterior Malleolus Fixation System is a medical device manufactured by TriMed, Inc.. It received FDA 510(k) clearance on 2024-11-26 under approval number K243050. 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 Posterior Malleolus Fixation System?

TriMed Posterior Malleolus Fixation System is a medical device that received FDA 510(k) clearance on 2024-11-26. It is manufactured by TriMed, Inc.. The 510(k) number is K243050.

When was TriMed Posterior Malleolus Fixation System approved by the FDA?

TriMed Posterior Malleolus Fixation System received FDA 510(k) clearance on 2024-11-26, under approval number K243050.

What company makes TriMed Posterior Malleolus Fixation System?

TriMed Posterior Malleolus Fixation System is manufactured by TriMed, Inc..

What is the FDA product code for TriMed Posterior Malleolus Fixation System?

The FDA product code for TriMed Posterior Malleolus Fixation System is HRS.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05391828 Persona MC vs PS RCT With ROSA RECRUITING NCT07277946 AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT07527299 A Study of VARIPULSE Catheter in Participants With Persistent Atrial Fibrillation Undergoing Pulmonary Vein and Superior Vena Cava Isolation NOT_YET_RECRUITING NCT02839850 14022 ATTUNE Cementless RP Clinical Performance Evaluation ACTIVE_NOT_RECRUITING

Other Devices by TriMed, Inc.

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Related Devices (Code: HRS)

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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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