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FDA 510(k)

GLOBAL UNITE Platform Shoulder System

K-Number: K170748 · 2018-01-11

ApplicantDepuy Ireland UC
Decision Date2018-01-11
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GLOBAL UNITE Platform Shoulder System is a medical device manufactured by Depuy Ireland UC. It received FDA 510(k) clearance on 2018-01-11 under approval number K170748. The device is classified under product code PHX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GLOBAL UNITE Platform Shoulder System?

GLOBAL UNITE Platform Shoulder System is a medical device that received FDA 510(k) clearance on 2018-01-11. It is manufactured by Depuy Ireland UC. The 510(k) number is K170748.

When was GLOBAL UNITE Platform Shoulder System approved by the FDA?

GLOBAL UNITE Platform Shoulder System received FDA 510(k) clearance on 2018-01-11, under approval number K170748.

What company makes GLOBAL UNITE Platform Shoulder System?

GLOBAL UNITE Platform Shoulder System is manufactured by Depuy Ireland UC.

What is the FDA product code for GLOBAL UNITE Platform Shoulder System?

The FDA product code for GLOBAL UNITE Platform Shoulder System is PHX.

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Related PubMed Literature

PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) PMID: 37288633 [Roadmap of Medical Device for Implanted Brain-computer Interface]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2023) PMID: 28502278 A NEW HEALTH TECHNOLOGY ASSESSMENT SYSTEM FOR DEVICES: THE FIRST FIVE YEARS. International journal of technology assessment in health care (2017)

Other Devices by Depuy Ireland UC

K202248Attune Revision Sleeve LPS Femoral Adaptors K202194ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology K202098GLOBAL UNITE™ Platform Shoulder System K200854DePuy PINNACLE Dual Mobility Liner K193549SIGMA High Performance (HP) Partial Knee System K193057ATTUNE All-Polyethylene Tibia

View all 48 devices →

Related Devices (Code: PHX)

K161742Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidTornier, Inc. K161189Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation K152754COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM (VRS)Biomet Manufacturing Corp K152966Aequalis Fx2Tornier S.A.S. K173073AltiVate Anatomic to Reverse Conversion ModuleEncore Medical L.P. K170414Arthrex Univers Revers Apex Humeral StemsArthrex, Inc.

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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