ULTIMA(TM) TOTAL HIP SYSTEM CEMENTED FEMORAL STEM

Prosthesis, Hip, Hemi-, Femoral, Metal

JOHNSON & JOHNSON ORTHOPAEDICS, INC.

The following data is part of a premarket notification filed by Johnson & Johnson Orthopaedics, Inc. with the FDA for Ultima(tm) Total Hip System Cemented Femoral Stem.

Pre-market Notification Details

Device IDK924379
510k NumberK924379
Device Name:ULTIMA(TM) TOTAL HIP SYSTEM CEMENTED FEMORAL STEM
ClassificationProsthesis, Hip, Hemi-, Femoral, Metal
Applicant JOHNSON & JOHNSON ORTHOPAEDICS, INC. Raynham,  MA  02767
ContactMarsha J Stone
CorrespondentMarsha J Stone
JOHNSON & JOHNSON ORTHOPAEDICS, INC. Raynham,  MA  02767
Product CodeKWL  
CFR Regulation Number888.3360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-08-31
Decision Date1993-02-12

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