DELTA XTEND REVERSE SHOULDER MODULAR STEM

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 Modular Stem.

Pre-market Notification Details

Device IDK071379
510k NumberK071379
Device Name:DELTA XTEND REVERSE SHOULDER MODULAR STEM
ClassificationShoulder Prosthesis, Reverse Configuration
Applicant DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw,  IN  46581 -0988
ContactNatalie S Heck
CorrespondentNatalie S Heck
DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw,  IN  46581 -0988
Product CodePHX  
Subsequent Product CodeHSD
Subsequent Product CodeKWS
CFR Regulation Number888.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-05-17
Decision Date2007-09-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10603295027331 K071379 000
10603295027171 K071379 000
10603295027225 K071379 000
10603295027270 K071379 000
10603295027287 K071379 000
10603295027294 K071379 000
10603295027300 K071379 000
10603295027317 K071379 000
10603295027324 K071379 000
10603295027126 K071379 000

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