DePuy Synthes Plates And Screws Portfolio

Plate, Fixation, Bone

DePuy Synthes

The following data is part of a premarket notification filed by Depuy Synthes with the FDA for Depuy Synthes Plates And Screws Portfolio.

Pre-market Notification Details

Device IDK190750
510k NumberK190750
Device Name:DePuy Synthes Plates And Screws Portfolio
ClassificationPlate, Fixation, Bone
Applicant DePuy Synthes 1301 Goshen Parkway West Chester,  PA  19380
ContactQuinn Mccarthy
CorrespondentQuinn Mccarthy
DePuy Synthes 1301 Goshen Parkway West Chester,  PA  19380
Product CodeHRS  
Subsequent Product CodeJDO
Subsequent Product CodeJDP
Subsequent Product CodeKTT
Subsequent Product CodeKTW
Subsequent Product CodeLXT
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-03-25
Decision Date2019-06-21

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