Global Shoulder And Delta CTA Systems

Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented

DePuy Lnc.

The following data is part of a premarket notification filed by Depuy Lnc. with the FDA for Global Shoulder And Delta Cta Systems.

Pre-market Notification Details

Device IDK203230
510k NumberK203230
Device Name:Global Shoulder And Delta CTA Systems
ClassificationProsthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
Applicant DePuy Lnc. 700 Orthopaedic Drive Warsaw,  IN  46581 -0988
ContactMegan Bernier
CorrespondentMegan Bernier
DePuy Lnc. 700 Orthopaedic Drive Warsaw,  IN  46581 -0988
Product CodeKWS  
Subsequent Product CodeHSD
Subsequent Product CodeKWT
Subsequent Product CodeMBF
Subsequent Product CodePHX
CFR Regulation Number888.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-02
Decision Date2021-04-02

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