MODIFICATION TO VERTEBROPLASTIC RADIOPAQUE BONE CEMENT

Cement, Bone, Vertebroplasty

DEPUY SPINE, A JOHNSON & JOHNSON COMPANY

The following data is part of a premarket notification filed by Depuy Spine, A Johnson & Johnson Company with the FDA for Modification To Vertebroplastic Radiopaque Bone Cement.

Pre-market Notification Details

Device IDK071927
510k NumberK071927
Device Name:MODIFICATION TO VERTEBROPLASTIC RADIOPAQUE BONE CEMENT
ClassificationCement, Bone, Vertebroplasty
Applicant DEPUY SPINE, A JOHNSON & JOHNSON COMPANY 325 Paramount Drive Raynham,  MA  02767
ContactSharon Starowicz
CorrespondentSharon Starowicz
DEPUY SPINE, A JOHNSON & JOHNSON COMPANY 325 Paramount Drive Raynham,  MA  02767
Product CodeNDN  
CFR Regulation Number888.3027 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-07-12
Decision Date2007-11-21
Summary:summary

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