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FDA 510(k)

Erisma-LP Spinal Fixation System

K-Number: K153326 · 2016-03-08

ApplicantClariance, Sas
Decision Date2016-03-08
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Erisma-LP Spinal Fixation System is a medical device manufactured by Clariance, Sas. It received FDA 510(k) clearance on 2016-03-08 under approval number K153326. 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 Spinal Fixation System?

Erisma-LP Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2016-03-08. It is manufactured by Clariance, Sas. The 510(k) number is K153326.

When was Erisma-LP Spinal Fixation System approved by the FDA?

Erisma-LP Spinal Fixation System received FDA 510(k) clearance on 2016-03-08, under approval number K153326.

What company makes Erisma-LP Spinal Fixation System?

Erisma-LP Spinal Fixation System is manufactured by Clariance, Sas.

What is the FDA product code for Erisma-LP Spinal Fixation System?

The FDA product code for Erisma-LP Spinal Fixation System is NKB.

Related Clinical Trials

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Related PubMed Literature

PMID: 35685299 Multicenter, Double-Blinded, Randomized, Active-Sham Controlled Clinical Study Design to Assess the Safety and Effectiveness of a Novel High Frequency Electric Nerve Block System in the Treatment of Post-Amputation Pain (The QUEST Study). Journal of pain research (2022)

Other Devices by Clariance, Sas

K162367Erisma® LP MIS K172465Idys™ TLIF 3DTi Cages K172083Idys™ ALIF System K170163Erisma® LP Spinal Fixation System K192168Idys ALIF ZP 3DTi K191263Idys ALIF TiVac

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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.

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