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 IDK003421
510k NumberK003421
Device Name:DEPUY C-STEM SYSTEM
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Cemented
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 CodeJDI  
CFR Regulation Number888.3350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-11-03
Decision Date2000-12-01

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10603295236849 K003421 000

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