FDA.report

510(k) K162134

Device
ENNOVATE Spinal System
Applicant
Aesculap Implant Systems, LLC
510(k) number
K162134
Product code
NKB  
Decision
Substantially Equivalent (SESE)
Decision date
2016-12-14
Date received
2016-08-01
Regulation
888.3070
Classification name
Thoracolumbosacral Pedicle Screw System
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Paul Amudala
Address
3773 Corporate Pkwy. Center Valley PA US 18034 18034

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Legacy Summary

summary

FDA Review

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