ULTIMA SIZE 0 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 Size 0 Cemented Femoral Stem.

Pre-market Notification Details

Device IDK953200
510k NumberK953200
Device Name:ULTIMA SIZE 0 CEMENTED FEMORAL STEM
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Applicant JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham,  MA  02767 -0350
ContactJ. Teresa Dorriety
CorrespondentJ. Teresa Dorriety
JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham,  MA  02767 -0350
Product CodeJDI  
CFR Regulation Number888.3350 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-07-10
Decision Date1996-01-31

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.