DEPUY GLOBAL SHOULDER GLENOID

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 Depuy Global Shoulder Glenoid.

Pre-market Notification Details

Device IDK981487
510k NumberK981487
Device Name:DEPUY GLOBAL SHOULDER GLENOID
ClassificationProsthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
Applicant DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw,  IN  46581 -0988
ContactSally Foust
CorrespondentSally Foust
DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw,  IN  46581 -0988
Product CodeKWS  
CFR Regulation Number888.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-04-27
Decision Date1998-07-13
Summary:summary

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