SYNTHES MATRIXNEURO CRANIAL PLATING SYSTEM

Plate, Cranioplasty, Preformed, Alterable

SYNTHES

The following data is part of a premarket notification filed by Synthes with the FDA for Synthes Matrixneuro Cranial Plating System.

Pre-market Notification Details

Device IDK123723
510k NumberK123723
Device Name:SYNTHES MATRIXNEURO CRANIAL PLATING SYSTEM
ClassificationPlate, Cranioplasty, Preformed, Alterable
Applicant SYNTHES 1301 Goshen Parkway West Chester,  PA  19380
ContactAlan T Haley
CorrespondentAlan T Haley
SYNTHES 1301 Goshen Parkway West Chester,  PA  19380
Product CodeGWO  
CFR Regulation Number882.5320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-12-04
Decision Date2013-09-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H98004503150S0 K123723 000
H98004503149S0 K123723 000
H98004503147S0 K123723 000
H98004503146S0 K123723 000
H98004503145S0 K123723 000

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