INSTINCT JAVA SYSTEM

Thoracolumbosacral Pedicle Screw System

ZIMMER SPINE

The following data is part of a premarket notification filed by Zimmer Spine with the FDA for Instinct Java System.

Pre-market Notification Details

Device IDK123552
510k NumberK123552
Device Name:INSTINCT JAVA SYSTEM
ClassificationThoracolumbosacral Pedicle Screw System
Applicant ZIMMER SPINE 7375 BUSH LAKE ROAD Edina,  MN  55439
ContactElsa A Linke
CorrespondentElsa A Linke
ZIMMER SPINE 7375 BUSH LAKE ROAD Edina,  MN  55439
Product CodeNKB  
Subsequent Product CodeMNH
Subsequent Product CodeMNI
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-11-19
Decision Date2013-04-19
Summary:summary

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