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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 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 2016-02-19 under 510(k) 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. The listed applicant is Custom Orthopaedic Solutions, Inc.. The 510(k) number is K153215.

When did SmartBase for Arthrex Glenoid IRIS receive FDA 510(k) clearance?

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

Who is the listed applicant for SmartBase for Arthrex Glenoid IRIS?

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 SmartBase for Arthrex Glenoid IRIS?

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

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 PortalK153612ArthrexVIP Web Portal

Related Devices (Code: KWS)

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.

K260721Tornier Perform Advanced GlenoidTornier, Inc.K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)Stryker Corporation (Tornier, 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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