Delta Xtend Revers Shoulder System

Shoulder Prosthesis, Reverse Configuration

DePuy(Ireland)

The following data is part of a premarket notification filed by Depuy(ireland) with the FDA for Delta Xtend Revers Shoulder System.

Pre-market Notification Details

Device IDK192448
510k NumberK192448
Device Name:Delta Xtend Revers Shoulder System
ClassificationShoulder Prosthesis, Reverse Configuration
Applicant DePuy(Ireland) Loughbeg Ringaskiddy Co.cork Munster,  IE
ContactAshley Goncalo
CorrespondentAshley Goncalo
DePuy Orthopaedies, Inc. 700 Orthopaedies Dr. Warsaw,  IN  46582
Product CodePHX  
CFR Regulation Number888.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-06
Decision Date2019-10-04

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