GROSS HIP FEMORAL COMPONENT

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

JOHNSON & JOHNSON ORTHOPAEDICS, INC.

The following data is part of a premarket notification filed by Johnson & Johnson Orthopaedics, Inc. with the FDA for Gross Hip Femoral Component.

Pre-market Notification Details

Device IDK904737
510k NumberK904737
Device Name:GROSS HIP FEMORAL COMPONENT
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Applicant JOHNSON & JOHNSON ORTHOPAEDICS, INC. Braintree,  MA  02184
ContactJ Stone
CorrespondentJ Stone
JOHNSON & JOHNSON ORTHOPAEDICS, INC. Braintree,  MA  02184
Product CodeJDI  
CFR Regulation Number888.3350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-10-18
Decision Date1991-07-26

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