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FDA 510(k)

Distal Xtremities System

K-Number: K252061 · 2025-08-20

ApplicantTriMed, Inc.
Decision Date2025-08-20
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Distal Xtremities System is a medical device manufactured by TriMed, Inc.. It received FDA 510(k) clearance on 2025-08-20 under approval number K252061. 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 Distal Xtremities System?

Distal Xtremities System is a medical device that received FDA 510(k) clearance on 2025-08-20. It is manufactured by TriMed, Inc.. The 510(k) number is K252061.

When was Distal Xtremities System approved by the FDA?

Distal Xtremities System received FDA 510(k) clearance on 2025-08-20, under approval number K252061.

What company makes Distal Xtremities System?

Distal Xtremities System is manufactured by TriMed, Inc..

What is the FDA product code for Distal Xtremities System?

The FDA product code for Distal Xtremities 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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