CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS

Prosthesis, Elbow, Semi-constrained, Cemented

JOHNSON & JOHNSON PROFESSIONALS, INC.

The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for Capitello-condylar Total Elbow Prosthesis.

Pre-market Notification Details

Device IDK983141
510k NumberK983141
Device Name:CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS
ClassificationProsthesis, Elbow, Semi-constrained, Cemented
Applicant JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham,  MA  02767
ContactDeana Boushell
CorrespondentDeana Boushell
JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham,  MA  02767
Product CodeJDB  
CFR Regulation Number888.3160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-09-08
Decision Date1998-11-06
Summary:summary

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