DEPUY C-STEM AMT HIP PROSTHESIS

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 Amt Hip Prosthesis.

Pre-market Notification Details

Device IDK042959
510k NumberK042959
Device Name:DEPUY C-STEM AMT HIP PROSTHESIS
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Applicant DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw,  IN  46581 -0988
ContactDina L Weissman
CorrespondentDina L Weissman
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 Received2004-10-27
Decision Date2004-12-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10603295060369 K042959 000
10603295059615 K042959 000
10603295059639 K042959 000
10603295059646 K042959 000
10603295059653 K042959 000
10603295059660 K042959 000
10603295059677 K042959 000
10603295060291 K042959 000
10603295060307 K042959 000
10603295060321 K042959 000
10603295060338 K042959 000
10603295060345 K042959 000
10603295060352 K042959 000
10603295059608 K042959 000

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