GLOBAL FX POROUS-COATED HUMERAL STEM

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 Fx Porous-coated Humeral Stem.

Pre-market Notification Details

Device IDK011099
510k NumberK011099
Device Name:GLOBAL FX POROUS-COATED HUMERAL STEM
ClassificationProsthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented
Applicant DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw,  IN  46581 -0988
ContactMarcia J Arentz
CorrespondentMarcia J Arentz
DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw,  IN  46581 -0988
Product CodeMBF  
CFR Regulation Number888.3670 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-04-11
Decision Date2001-07-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10603295005056 K011099 000
10603295005025 K011099 000
10603295004998 K011099 000
10603295004967 K011099 000

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