SYNTHES MATRIX SYSTEM

Thoracolumbosacral Pedicle Screw System

SYNTHES SPINE

The following data is part of a premarket notification filed by Synthes Spine with the FDA for Synthes Matrix System.

Pre-market Notification Details

Device IDK120928
510k NumberK120928
Device Name:SYNTHES MATRIX SYSTEM
ClassificationThoracolumbosacral Pedicle Screw System
Applicant SYNTHES SPINE 1302 WRIGHTS LN EAST West Chester,  PA  19380
ContactHeather Guerin
CorrespondentHeather Guerin
SYNTHES SPINE 1302 WRIGHTS LN EAST West Chester,  PA  19380
Product CodeNKB  
Subsequent Product CodeKWP
Subsequent Product CodeKWQ
Subsequent Product CodeMNH
Subsequent Product CodeMNI
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-03-27
Decision Date2012-05-18
Summary:summary

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