DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm)

Plate, Bone

Synthes (USA) Products, LLC

The following data is part of a premarket notification filed by Synthes (usa) Products, Llc with the FDA for Depuy Synthes 2.4mm Ti Self-tapping Matrixmandible Screws (26-40mm).

Pre-market Notification Details

Device IDK201944
510k NumberK201944
Device Name:DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm)
ClassificationPlate, Bone
Applicant Synthes (USA) Products, LLC 1301 Goshen Parkway West Chester,  PA  19380
ContactPrem Pisupati
CorrespondentPrem Pisupati
Synthes (USA) Products, LLC 1301 Goshen Parkway West Chester,  PA  19380
Product CodeJEY  
CFR Regulation Number872.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-13
Decision Date2020-09-10

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.