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FDA 510(k)

DELTA XTEND(TM) Reverse Shoulder System

K-Number: K192855 · 2020-02-24

ApplicantDepuy(Ireland)
Decision Date2020-02-24
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DELTA XTEND(TM) Reverse Shoulder System is a medical device manufactured by Depuy(Ireland). It received FDA 510(k) clearance on 2020-02-24 under approval number K192855. 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 DELTA XTEND(TM) Reverse Shoulder System?

DELTA XTEND(TM) Reverse Shoulder System is a medical device that received FDA 510(k) clearance on 2020-02-24. It is manufactured by Depuy(Ireland). The 510(k) number is K192855.

When was DELTA XTEND(TM) Reverse Shoulder System approved by the FDA?

DELTA XTEND(TM) Reverse Shoulder System received FDA 510(k) clearance on 2020-02-24, under approval number K192855.

What company makes DELTA XTEND(TM) Reverse Shoulder System?

DELTA XTEND(TM) Reverse Shoulder System is manufactured by Depuy(Ireland).

What is the FDA product code for DELTA XTEND(TM) Reverse Shoulder System?

The FDA product code for DELTA XTEND(TM) Reverse Shoulder System is PHX.

Related Clinical Trials

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Related PubMed Literature

PMID: 42173476 Feasibility of applying the Orthopaedic Data Evaluation Panel (ODEP) shoulder criteria for implants used in a United States-based integrated healthcare system. Journal of shoulder and elbow surgery (2026)

Other Devices by Depuy(Ireland)

K160907DePuy Actis DuoFix Hip Prosthesis K160700ATTUNE Revision Knee System K170806ATTUNE Cemented Tibial Base, Fixed Bearing K190344DePuy Corail AMT Hip Prosthesis K191779Attune Revision LPS Inserts K192448Delta Xtend Revers Shoulder System

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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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