Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Delta Xtend Revers Shoulder System

K-Number: K192448 · 2019-10-04

ApplicantDepuy(Ireland)
Decision Date2019-10-04
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Delta Xtend Revers Shoulder System is a medical device manufactured by Depuy(Ireland). It received FDA 510(k) clearance on 2019-10-04 under approval number K192448. 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 Revers Shoulder System?

Delta Xtend Revers Shoulder System is a medical device that received FDA 510(k) clearance on 2019-10-04. It is manufactured by Depuy(Ireland). The 510(k) number is K192448.

When was Delta Xtend Revers Shoulder System approved by the FDA?

Delta Xtend Revers Shoulder System received FDA 510(k) clearance on 2019-10-04, under approval number K192448.

What company makes Delta Xtend Revers Shoulder System?

Delta Xtend Revers Shoulder System is manufactured by Depuy(Ireland).

What is the FDA product code for Delta Xtend Revers Shoulder System?

The FDA product code for Delta Xtend Revers Shoulder System is PHX.

Related Clinical Trials

NCT07544654 DAREON®-NEC-1: A Study in People With Advanced Extrapulmonary Neuroendocrine Cancer to Compare Obrixtamig Plus Carboplatin and Etoposide Treatment With Standard Chemotherapy NOT_YET_RECRUITING NCT04816825 Home-monitored Telerehabilitation in COPD Patients COMPLETED NCT07464977 EMG and Delta Function in Standard RTSA vs Lateralization NOT_YET_RECRUITING NCT05951491 Improving Arm Function Using Wearable Exoskeletons SUSPENDED NCT04984291 Zimmer Biomet Shoulder Arthroplasty PMCF RECRUITING NCT01480440 Outcomes Study of the Trabecular Metal (TM) Reverse Shoulder System ACTIVE_NOT_RECRUITING

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 K183077Delta Xtend Reverse Shoulder System

View all 9 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.

↑