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FDA 510(k)

SmartBase for Arthrex Glenoid IRIS

K-Number: K153215 · 2016-02-19

ApplicantCustom Orthopaedic Solutions, Inc.
Decision Date2016-02-19
Product CodeKWS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SmartBase for Arthrex Glenoid IRIS is a medical device manufactured by Custom Orthopaedic Solutions, Inc.. It received FDA 510(k) clearance on 2016-02-19 under approval number K153215. The device is classified under product code KWS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SmartBase for Arthrex Glenoid IRIS?

SmartBase for Arthrex Glenoid IRIS is a medical device that received FDA 510(k) clearance on 2016-02-19. It is manufactured by Custom Orthopaedic Solutions, Inc.. The 510(k) number is K153215.

When was SmartBase for Arthrex Glenoid IRIS approved by the FDA?

SmartBase for Arthrex Glenoid IRIS received FDA 510(k) clearance on 2016-02-19, under approval number K153215.

What company makes SmartBase for Arthrex Glenoid IRIS?

SmartBase for Arthrex Glenoid IRIS is manufactured by Custom Orthopaedic Solutions, Inc..

What is the FDA product code for SmartBase for Arthrex Glenoid IRIS?

The FDA product code for SmartBase for Arthrex Glenoid IRIS is KWS.

Other Devices by Custom Orthopaedic Solutions, Inc.

K153612ArthrexVIP Web Portal K162697Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative Plan, SmartBase for Arthrex Glenoid IRIS, ArthrexVIP Web Portal

Related Devices (Code: KWS)

K161789BLUEPRINT Patient Specific InstrumentationTornier S.A.S. K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA), ReUnion Total Shoulder Arthroplasty (TSA)Stryker GmbH K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P. K161108Arthrex VaultLock GlenoidArthrex, Inc. K160975Aequalis PerFORM+ Shoulder SystemTornier, Inc. K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S.

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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