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FDA 510(k)

TriMed Elbow and Forearm System

K-Number: K243987 · 2025-03-19

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

Device Summary

TriMed Elbow and Forearm System is a medical device manufactured by TriMed, Inc.. It received FDA 510(k) clearance on 2025-03-19 under approval number K243987. 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 Elbow and Forearm System?

TriMed Elbow and Forearm 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 K243987.

When was TriMed Elbow and Forearm System approved by the FDA?

TriMed Elbow and Forearm System received FDA 510(k) clearance on 2025-03-19, under approval number K243987.

What company makes TriMed Elbow and Forearm System?

TriMed Elbow and Forearm System is manufactured by TriMed, Inc..

What is the FDA product code for TriMed Elbow and Forearm System?

The FDA product code for TriMed Elbow and Forearm System is 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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