DEPUY SIGMA CR-F FEMORAL COMPONENT

Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

DEPUY ORTHOPAEDICS, INC.

The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Depuy Sigma Cr-f Femoral Component.

Pre-market Notification Details

Device IDK082500
510k NumberK082500
Device Name:DEPUY SIGMA CR-F FEMORAL COMPONENT
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw,  IN  46581 -0988
ContactNancy Friddle
CorrespondentNancy Friddle
DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw,  IN  46581 -0988
Product CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-08-29
Decision Date2008-11-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10603295074991 K082500 000
10603295074892 K082500 000
10603295074908 K082500 000
10603295074939 K082500 000
10603295074830 K082500 000
10603295074847 K082500 000
10603295074854 K082500 000
10603295074861 K082500 000
10603295074878 K082500 000
10603295074922 K082500 000
10603295074946 K082500 000
10603295074953 K082500 000
10603295074960 K082500 000
10603295074977 K082500 000
10603295074984 K082500 000
10603295074885 K082500 000

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