FDA 510(k)

Erisma® LP MIS

K-Number: K162367 · 2016-10-27

Decision Date2016-10-27

Product CodeNKB

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Erisma® LP MIS is a medical device manufactured by Clariance, Sas. It received FDA 510(k) clearance on 2016-10-27 under approval number K162367. 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 Erisma® LP MIS?

Erisma® LP MIS is a medical device that received FDA 510(k) clearance on 2016-10-27. It is manufactured by Clariance, Sas. The 510(k) number is K162367.

When was Erisma® LP MIS approved by the FDA?

Erisma® LP MIS received FDA 510(k) clearance on 2016-10-27, under approval number K162367.

What company makes Erisma® LP MIS?

Erisma® LP MIS is manufactured by Clariance, Sas.

What is the FDA product code for Erisma® LP MIS?

The FDA product code for Erisma® LP MIS is NKB.

Other Devices by Clariance, Sas

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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

View on FDA Database →

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