SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM

Plate, Bone

SYNTHES INC

The following data is part of a premarket notification filed by Synthes Inc with the FDA for Synthes Matrixmadible Plate And Screw System.

Pre-market Notification Details

Device IDK113567
510k NumberK113567
Device Name:SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM
ClassificationPlate, Bone
Applicant SYNTHES INC 1301 Goshen Parkway West Chester,  PA  19380
ContactAlan T Haley
CorrespondentAlan T Haley
SYNTHES INC 1301 Goshen Parkway West Chester,  PA  19380
Product CodeJEY  
CFR Regulation Number872.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-12-02
Decision Date2012-11-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H980045037890 K113567 000
H980045037880 K113567 000
H980045037870 K113567 000
H980045037860 K113567 000
H980045037850 K113567 000

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