GLOBAL ADVANTAGE HUMERAL STEM WITH POROCOAT

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

DEPUY ORTHOPAEDICS, INC.

The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Global Advantage Humeral Stem With Porocoat.

Pre-market Notification Details

Device IDK011047
510k NumberK011047
Device Name:GLOBAL ADVANTAGE HUMERAL STEM WITH POROCOAT
ClassificationProsthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented
Applicant DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DR. Warsaw,  IN  46581 -0988
ContactMarcia Arentz
CorrespondentMarcia Arentz
DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DR. Warsaw,  IN  46581 -0988
Product CodeMBF  
CFR Regulation Number888.3670 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-04-06
Decision Date2001-06-28

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