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FDA 510(k)

DELTA XTEND Reverse Shoulder System

K-Number: K210167 · 2021-02-19

ApplicantDePuy Orthopaedics, Inc.
Decision Date2021-02-19
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DELTA XTEND Reverse Shoulder System is a medical device manufactured by DePuy Orthopaedics, Inc.. It received FDA 510(k) clearance on 2021-02-19 under approval number K210167. 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 Reverse Shoulder System?

DELTA XTEND Reverse Shoulder System is a medical device that received FDA 510(k) clearance on 2021-02-19. It is manufactured by DePuy Orthopaedics, Inc.. The 510(k) number is K210167.

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

DELTA XTEND Reverse Shoulder System received FDA 510(k) clearance on 2021-02-19, under approval number K210167.

What company makes DELTA XTEND Reverse Shoulder System?

DELTA XTEND Reverse Shoulder System is manufactured by DePuy Orthopaedics, Inc..

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

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

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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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