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FDA 510(k)

TriMed Fusion Cup System

K-Number: K250948 · 2025-04-08

ApplicantTriMed, Inc.
Decision Date2025-04-08
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TriMed Fusion Cup System is a medical device manufactured by TriMed, Inc.. It received FDA 510(k) clearance on 2025-04-08 under approval number K250948. 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 Fusion Cup System?

TriMed Fusion Cup System is a medical device that received FDA 510(k) clearance on 2025-04-08. It is manufactured by TriMed, Inc.. The 510(k) number is K250948.

When was TriMed Fusion Cup System approved by the FDA?

TriMed Fusion Cup System received FDA 510(k) clearance on 2025-04-08, under approval number K250948.

What company makes TriMed Fusion Cup System?

TriMed Fusion Cup System is manufactured by TriMed, Inc..

What is the FDA product code for TriMed Fusion Cup System?

The FDA product code for TriMed Fusion Cup 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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