POROUS COATED ACETABULAR CUP

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 Porous Coated Acetabular Cup.

Pre-market Notification Details

Device IDK873585
510k NumberK873585
Device Name:POROUS COATED ACETABULAR CUP
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Applicant JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham,  MA  02767 -0350
ContactMarsha J Stone
CorrespondentMarsha J Stone
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 Received1987-09-04
Decision Date1987-10-28

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