DELTA XTEND Reverse Shoulder System

Shoulder Prosthesis, Reverse Configuration

DePuy Orthopaedics Inc.

The following data is part of a premarket notification filed by Depuy Orthopaedics Inc. with the FDA for Delta Xtend Reverse Shoulder System.

Pre-market Notification Details

Device IDK210167
510k NumberK210167
Device Name:DELTA XTEND Reverse Shoulder System
ClassificationShoulder Prosthesis, Reverse Configuration
Applicant DePuy Orthopaedics Inc. 700 Orthopaedic Drive Warsaw,  IN  46582
ContactMegan Bernier
CorrespondentMegan Bernier
DePuy Orthopaedics Inc. 700 Orthopaedic Drive Warsaw,  IN  46582
Product CodePHX  
Subsequent Product CodeHSD
Subsequent Product CodeKWS
CFR Regulation Number888.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-21
Decision Date2021-02-19

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