DEPUY C-STEM SYSTEM

Prosthesis, Hip, 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 C-stem System.

Pre-market Notification Details

Device IDK982918
510k NumberK982918
Device Name:DEPUY C-STEM SYSTEM
ClassificationProsthesis, Hip, 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 CodeJDI  
Subsequent Product CodeLZN
Subsequent Product CodeLZO
CFR Regulation Number888.3350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-08-19
Decision Date1998-10-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10603295236801 K982918 000
10603295235231 K982918 000
10603295235224 K982918 000
10603295235217 K982918 000
10603295235200 K982918 000
10603295235194 K982918 000
10603295235187 K982918 000
10603295235170 K982918 000
10603295236351 K982918 000
10603295235248 K982918 000
10603295235255 K982918 000
10603295236795 K982918 000
10603295236788 K982918 000
10603295236771 K982918 000
10603295236764 K982918 000
10603295236757 K982918 000
10603295235286 K982918 000
10603295235279 K982918 000
10603295235262 K982918 000
10603295235958 K982918 000

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