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 IDK062250
510k NumberK062250
Device Name:DELTA XTEND REVERSE SHOULDER SYSTEM
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 Received2006-08-02
Decision Date2007-02-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10603295027102 K062250 000
10603295027256 K062250 000
10603295027263 K062250 000
10603295027348 K062250 000
10603295027355 K062250 000
10603295027362 K062250 000
10603295027379 K062250 000
10603295027386 K062250 000
10603295027522 K062250 000
10603295027249 K062250 000
10603295027232 K062250 000
10603295027218 K062250 000
10603295027119 K062250 000
10603295027133 K062250 000
10603295027140 K062250 000
10603295027157 K062250 000
10603295027164 K062250 000
10603295027188 K062250 000
10603295027195 K062250 000
10603295027201 K062250 000
10603295027539 K062250 000
10603295027546 K062250 000
10603295027805 K062250 000
10603295027812 K062250 000
10603295027829 K062250 000
10603295027836 K062250 000
10603295027843 K062250 000
10603295027850 K062250 000
10603295027867 K062250 000
10603295027874 K062250 000
10603295027799 K062250 000
10603295027782 K062250 000
10603295027775 K062250 000
10603295027553 K062250 000
10603295027690 K062250 000
10603295027706 K062250 000
10603295027713 K062250 000
10603295027720 K062250 000
10603295027744 K062250 000
10603295027751 K062250 000
10603295027768 K062250 000
10603295027737 K062250 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.