FDA 510(k)

ENNOVATE®

K-Number: K180433 · 2018-04-26

Decision Date2018-04-26

Product CodeNKB

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

ENNOVATE® is a medical device manufactured by Aesculap Implant Systems, LLC. It received FDA 510(k) clearance on 2018-04-26 under approval number K180433. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENNOVATE®?

ENNOVATE® is a medical device that received FDA 510(k) clearance on 2018-04-26. It is manufactured by Aesculap Implant Systems, LLC. The 510(k) number is K180433.

When was ENNOVATE® approved by the FDA?

ENNOVATE® received FDA 510(k) clearance on 2018-04-26, under approval number K180433.

What company makes ENNOVATE®?

ENNOVATE® is manufactured by Aesculap Implant Systems, LLC.

What is the FDA product code for ENNOVATE®?

The FDA product code for ENNOVATE® is NKB.

Other Devices by Aesculap Implant Systems, LLC

K162134ENNOVATE Spinal System K153700Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments K153396Aesculap OrthoPilot Next Generation K210963ENNOVATE Spinal System K213871Ennovate Cervical Spinal and Occiput System

Related Devices (Code: NKB)

K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc. K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC K162912VIPER PRIME additions to the VIPER® SystemMedos International SARL K162160Preference Elite Pedicle Screw SystemAmedica Corporation K162232MOSS 100 Pedicle Screw SystemBiedermann Motech GmbH & Co. KG K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.