FDA 510(k)

Arisstos Spinal System

K-Number: K173126 · 2017-12-05

Decision Date2017-12-05

Product CodeNKB

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Arisstos Spinal System is a medical device manufactured by Ingenium Spine. It received FDA 510(k) clearance on 2017-12-05 under approval number K173126. 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 Arisstos Spinal System?

Arisstos Spinal System is a medical device that received FDA 510(k) clearance on 2017-12-05. It is manufactured by Ingenium Spine. The 510(k) number is K173126.

When was Arisstos Spinal System approved by the FDA?

Arisstos Spinal System received FDA 510(k) clearance on 2017-12-05, under approval number K173126.

What company makes Arisstos Spinal System?

Arisstos Spinal System is manufactured by Ingenium Spine.

What is the FDA product code for Arisstos Spinal System?

The FDA product code for Arisstos Spinal System is NKB.

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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 Ingenium Spine

K241258Ingenix Spinal 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.