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FDA 510(k)

Arzzt 3.5 / 4.5 Small & Large Fragments System

K-Number: K162507 · 2017-08-03

ApplicantTruemed Group, LLC
Decision Date2017-08-03
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arzzt 3.5 / 4.5 Small & Large Fragments System is a medical device manufactured by Truemed Group, LLC. It received FDA 510(k) clearance on 2017-08-03 under approval number K162507. 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 Arzzt 3.5 / 4.5 Small & Large Fragments System?

Arzzt 3.5 / 4.5 Small & Large Fragments System is a medical device that received FDA 510(k) clearance on 2017-08-03. It is manufactured by Truemed Group, LLC. The 510(k) number is K162507.

When was Arzzt 3.5 / 4.5 Small & Large Fragments System approved by the FDA?

Arzzt 3.5 / 4.5 Small & Large Fragments System received FDA 510(k) clearance on 2017-08-03, under approval number K162507.

What company makes Arzzt 3.5 / 4.5 Small & Large Fragments System?

Arzzt 3.5 / 4.5 Small & Large Fragments System is manufactured by Truemed Group, LLC.

What is the FDA product code for Arzzt 3.5 / 4.5 Small & Large Fragments System?

The FDA product code for Arzzt 3.5 / 4.5 Small & Large Fragments System is HRS.

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Related PubMed Literature

PMID: 42168293 Comparative in vitro and in vivo assessment of three experimental extracellular matrix meshes for soft tissue remodeling. Scientific reports (2026)

Other Devices by Truemed Group, LLC

K172189Ins Hilden Humeral Arzzt, Ins Hilden Cannulated Tibial Arzzt, Ins Hilden Femoral Arzzt & Ins Hilden Retrograde Femoral Arzzt K182650Arzzt Distal Radius and Ulna System K200575TRUEMED HAND, FOOT AND ANKLE PLATES SYSTEM

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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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