MODIFICATION TO DEPUY DELTA XTEND REVERSE SHOULDER SYSTEM

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

DEPUY ORTHOPAEDICS, INC.

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

Pre-market Notification Details

Device IDK081620
510k NumberK081620
Device Name:MODIFICATION TO DEPUY DELTA XTEND REVERSE SHOULDER SYSTEM
ClassificationProsthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
Applicant DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw,  IN  46581 -0988
ContactRhonda Myer
CorrespondentRhonda Myer
DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw,  IN  46581 -0988
Product CodeKWS  
Subsequent Product CodeHSD
Subsequent Product CodePHX
CFR Regulation Number888.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-06-09
Decision Date2008-06-30
Summary:summary

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