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 Synthes Matrixmandible Plate And Screw System.

Pre-market Notification Details

Device IDK082335
510k NumberK082335
Device Name:SYNTHES MATRIXMANDIBLE PLATE AND SCREW SYSTEM
ClassificationPlate, Bone
Applicant SYNTHES (USA) 1301 GOSHEN PKWY. West Chester,  PA  19380
ContactAmnon Talmor
CorrespondentAmnon Talmor
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 Received2008-08-14
Decision Date2008-11-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H98004503548050 K082335 000
H98004503546050 K082335 000
H98004503508050 K082335 000
H98004503506050 K082335 000
H98004503548010 K082335 000
H98004503546010 K082335 000
H98004503508010 K082335 000
H98004503506010 K082335 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.