DEPUY TOTAL ELBOW SYSTEM

Prosthesis, Elbow, Constrained, Cemented

DEPUY ORTHOPAEDICS, INC.

The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Depuy Total Elbow System.

Pre-market Notification Details

Device IDK992656
510k NumberK992656
Device Name:DEPUY TOTAL ELBOW SYSTEM
ClassificationProsthesis, Elbow, Constrained, Cemented
Applicant DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw,  IN  46581 -0988
ContactJanet G Johnson
CorrespondentJanet G Johnson
DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw,  IN  46581 -0988
Product CodeJDC  
CFR Regulation Number888.3150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-08-09
Decision Date1999-11-05
Summary:summary

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