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FDA 510(k)

INNOVERSE Spinal System

K-Number: K233960 · 2024-02-06

ApplicantInnosys Co., Ltd.
Decision Date2024-02-06
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INNOVERSE Spinal System is a medical device manufactured by Innosys Co., Ltd.. It received FDA 510(k) clearance on 2024-02-06 under approval number K233960. 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 INNOVERSE Spinal System?

INNOVERSE Spinal System is a medical device that received FDA 510(k) clearance on 2024-02-06. It is manufactured by Innosys Co., Ltd.. The 510(k) number is K233960.

When was INNOVERSE Spinal System approved by the FDA?

INNOVERSE Spinal System received FDA 510(k) clearance on 2024-02-06, under approval number K233960.

What company makes INNOVERSE Spinal System?

INNOVERSE Spinal System is manufactured by Innosys Co., Ltd..

What is the FDA product code for INNOVERSE Spinal System?

The FDA product code for INNOVERSE Spinal 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 Innosys Co., Ltd.

K231737ANAX™ 5.5 Spinal System K241082INNOVERSE Navigation Instruments K234119UniSpace® Stand-Alone C Cage

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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