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FDA 510(k)

GLOBAL ICON Stemless Shoulder System

K-Number: K212683 · 2022-01-19

ApplicantDepuy(Ireland)
Decision Date2022-01-19
Product CodePKC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GLOBAL ICON Stemless Shoulder System is the device name listed in this FDA 510(k) record. The listed applicant is Depuy(Ireland). It received FDA 510(k) clearance on 2022-01-19 under 510(k) number K212683. The device is classified under product code PKC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GLOBAL ICON Stemless Shoulder System?

GLOBAL ICON Stemless Shoulder System is a medical device that received FDA 510(k) clearance on 2022-01-19. The listed applicant is Depuy(Ireland). The 510(k) number is K212683.

When did GLOBAL ICON Stemless Shoulder System receive FDA 510(k) clearance?

GLOBAL ICON Stemless Shoulder System received FDA 510(k) clearance on 2022-01-19, under 510(k) number K212683.

Who is the listed applicant for GLOBAL ICON Stemless Shoulder System?

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

What is the FDA product code for GLOBAL ICON Stemless Shoulder System?

The FDA product code for GLOBAL ICON Stemless Shoulder System is PKC.

Other records listing Depuy(Ireland) 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.

K192855DELTA XTEND(TM) Reverse Shoulder SystemK190344DePuy Corail AMT Hip ProsthesisK191779Attune Revision LPS InsertsK192448Delta Xtend Revers Shoulder SystemK183077Delta Xtend Reverse Shoulder SystemK170806ATTUNE Cemented Tibial Base, Fixed Bearing

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Related Devices (Code: PKC)

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.

K254154FX V135 EASYTECH® Shoulder SystemFX Shoulder Solutions, Inc.K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.K243248INHANCE INTACT™Depuy Ireland UCK241873OsseoFit Stemless Shoulder SystemZimmer, Inc.K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.K221758SMR Stemless AnatomicLima Corporate S.P.A.

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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