DELTA XTEND(TM) Reverse 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(tm) Reverse Shoulder System.

Pre-market Notification Details

Device IDK192855
510k NumberK192855
Device Name:DELTA XTEND(TM) Reverse Shoulder System
ClassificationShoulder Prosthesis, Reverse Configuration
Applicant DePuy (Ireland) Loughbeg Ringaskiddy County Cork,  IE
ContactAshley Goncalo
CorrespondentAshley Goncalo
Depuy Orthopaedics, Inc 325 Paramount Drive Raynham,  MA  02767
Product CodePHX  
CFR Regulation Number888.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-04
Decision Date2020-02-24

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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10603295518785 K192855 000

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