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FDA 510(k)

ArthrexVIP Web Portal

K-Number: K153612 · 2016-03-15

ApplicantCustom Orthopaedic Solutions, Inc.
Decision Date2016-03-15
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ArthrexVIP Web Portal is a medical device manufactured by Custom Orthopaedic Solutions, Inc.. It received FDA 510(k) clearance on 2016-03-15 under approval number K153612. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ArthrexVIP Web Portal?

ArthrexVIP Web Portal is a medical device that received FDA 510(k) clearance on 2016-03-15. It is manufactured by Custom Orthopaedic Solutions, Inc.. The 510(k) number is K153612.

When was ArthrexVIP Web Portal approved by the FDA?

ArthrexVIP Web Portal received FDA 510(k) clearance on 2016-03-15, under approval number K153612.

What company makes ArthrexVIP Web Portal?

ArthrexVIP Web Portal is manufactured by Custom Orthopaedic Solutions, Inc..

What is the FDA product code for ArthrexVIP Web Portal?

The FDA product code for ArthrexVIP Web Portal is LLZ.

Other Devices by Custom Orthopaedic Solutions, Inc.

K153215SmartBase for Arthrex Glenoid IRIS K162697Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative Plan, SmartBase for Arthrex Glenoid IRIS, ArthrexVIP Web Portal

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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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