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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 the device name listed in this FDA 510(k) record. The listed applicant is Custom Orthopaedic Solutions, Inc.. It received FDA 510(k) clearance on 2016-03-15 under 510(k) 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. The listed applicant is Custom Orthopaedic Solutions, Inc.. The 510(k) number is K153612.

When did ArthrexVIP Web Portal receive FDA 510(k) clearance?

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

Who is the listed applicant for ArthrexVIP Web Portal?

The FDA 510(k) record lists Custom Orthopaedic Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ArthrexVIP Web Portal?

The FDA product code for ArthrexVIP Web Portal is LLZ.

Other records listing Custom Orthopaedic Solutions, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K162697Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative Plan, SmartBase for Arthrex Glenoid IRIS, ArthrexVIP Web PortalK153215SmartBase for Arthrex Glenoid IRIS

Related Devices (Code: LLZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262449AdvaViewADVAHEALTH SOLUTIONS, LLCK261916NeuroQuant PETCortechs Labs, Inc.K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K260588Cleerly LABSCleerly, Inc.K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific CorporationK262143ImageGrid StreamVueCandelis, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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