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FDA 510(k)

Arthrex Synergy UHD4 System

K-Number: K153218 · 2016-02-12

ApplicantArthrex, Inc.
Decision Date2016-02-12
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Arthrex Synergy UHD4 System is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2016-02-12 under approval number K153218. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Arthrex Synergy UHD4 System?

Arthrex Synergy UHD4 System is a medical device that received FDA 510(k) clearance on 2016-02-12. It is manufactured by Arthrex, Inc.. The 510(k) number is K153218.

When was Arthrex Synergy UHD4 System approved by the FDA?

Arthrex Synergy UHD4 System received FDA 510(k) clearance on 2016-02-12, under approval number K153218.

What company makes Arthrex Synergy UHD4 System?

Arthrex Synergy UHD4 System is manufactured by Arthrex, Inc..

What is the FDA product code for Arthrex Synergy UHD4 System?

The FDA product code for Arthrex Synergy UHD4 System is GCJ.

Related Clinical Trials

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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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