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FDA 510(k)

GLENOID INTELLIGENT REUSABLE INSTRUMENT SYSTEM (GLENOID IRIS)

K-Number: K123122 · 2013-04-05

ApplicantCleveland Clinic
Decision Date2013-04-05
Product CodeKWS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GLENOID INTELLIGENT REUSABLE INSTRUMENT SYSTEM (GLENOID IRIS) is the device name listed in this FDA 510(k) record. The listed applicant is Cleveland Clinic. It received FDA 510(k) clearance on 2013-04-05 under 510(k) number K123122. 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 GLENOID INTELLIGENT REUSABLE INSTRUMENT SYSTEM (GLENOID IRIS)?

GLENOID INTELLIGENT REUSABLE INSTRUMENT SYSTEM (GLENOID IRIS) is a medical device that received FDA 510(k) clearance on 2013-04-05. The listed applicant is Cleveland Clinic. The 510(k) number is K123122.

When did GLENOID INTELLIGENT REUSABLE INSTRUMENT SYSTEM (GLENOID IRIS) receive FDA 510(k) clearance?

GLENOID INTELLIGENT REUSABLE INSTRUMENT SYSTEM (GLENOID IRIS) received FDA 510(k) clearance on 2013-04-05, under 510(k) number K123122.

Who is the listed applicant for GLENOID INTELLIGENT REUSABLE INSTRUMENT SYSTEM (GLENOID IRIS)?

The FDA 510(k) record lists Cleveland Clinic as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GLENOID INTELLIGENT REUSABLE INSTRUMENT SYSTEM (GLENOID IRIS)?

The FDA product code for GLENOID INTELLIGENT REUSABLE INSTRUMENT SYSTEM (GLENOID IRIS) is KWS.

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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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