DEPUY C-STEM AMT

Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component)

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.

Pre-market Notification Details

Device IDK082239
510k NumberK082239
Device Name:DEPUY C-STEM AMT
ClassificationProsthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component)
Applicant DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DR. Warsaw,  IN  46582
ContactRhonda Myer
CorrespondentRhonda Myer
DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DR. Warsaw,  IN  46582
Product CodeKWA  
Subsequent Product CodeJDI
Subsequent Product CodeLPH
Subsequent Product CodeLZO
CFR Regulation Number888.3330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-08-07
Decision Date2008-08-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10603295060284 K082239 000
10603295059592 K082239 000

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