ULTIMA AND ULTIMA LX CEMENTED FEMORAL STEM

Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

JOHNSON & JOHNSON PROFESSIONALS, INC.

The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for Ultima And Ultima Lx Cemented Femoral Stem.

Pre-market Notification Details

Device IDK972435
510k NumberK972435
Device Name:ULTIMA AND ULTIMA LX CEMENTED FEMORAL STEM
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Applicant JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham,  MA  02767
ContactMary E Gray
CorrespondentMary E Gray
JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham,  MA  02767
Product CodeJDI  
CFR Regulation Number888.3350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-06-30
Decision Date1997-09-11
Summary:summary

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