THE SYNTHES MATRIXMANDIBLE PLATE AND SCREW SYSTEM

Plate, Bone

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for The Synthes Matrixmandible Plate And Screw System.

Pre-market Notification Details

Device IDK063790
510k NumberK063790
Device Name:THE SYNTHES MATRIXMANDIBLE PLATE AND SCREW SYSTEM
ClassificationPlate, Bone
Applicant SYNTHES (USA) 1301 GOSHEN PKWY West Chester,  PA  19380
ContactDeborah L Jackson
CorrespondentDeborah L Jackson
SYNTHES (USA) 1301 GOSHEN PKWY West Chester,  PA  19380
Product CodeJEY  
CFR Regulation Number872.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-12-22
Decision Date2007-04-16
Summary:summary

NIH GUDID Devices

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