ENNOVATE Spinal System

Thoracolumbosacral Pedicle Screw System

Aesculap Implant Systems, LLC

The following data is part of a premarket notification filed by Aesculap Implant Systems, Llc with the FDA for Ennovate Spinal System.

Pre-market Notification Details

Device IDK162134
510k NumberK162134
Device Name:ENNOVATE Spinal System
ClassificationThoracolumbosacral Pedicle Screw System
Applicant Aesculap Implant Systems, LLC 3773 Corporate Parkway Center Valley,  PA  18034
ContactPaul Amudala
CorrespondentPaul Amudala
Aesculap Implant Systems, LLC 3773 Corporate Parkway Center Valley,  PA  18034
Product CodeNKB  
Subsequent Product CodeKWQ
Subsequent Product CodeMNH
Subsequent Product CodeMNI
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-08-01
Decision Date2016-12-14
Summary:summary

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