FDA 510(k)

ANAX 5.5 Spinal System

K-Number: K231737 · 2023-10-26

Decision Date2023-10-26

Product CodeNKB

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

ANAX 5.5 Spinal System is a medical device manufactured by Innosys Co., Ltd.. It received FDA 510(k) clearance on 2023-10-26 under approval number K231737. 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 ANAX 5.5 Spinal System?

ANAX 5.5 Spinal System is a medical device that received FDA 510(k) clearance on 2023-10-26. It is manufactured by Innosys Co., Ltd.. The 510(k) number is K231737.

When was ANAX 5.5 Spinal System approved by the FDA?

ANAX 5.5 Spinal System received FDA 510(k) clearance on 2023-10-26, under approval number K231737.

What company makes ANAX 5.5 Spinal System?

ANAX 5.5 Spinal System is manufactured by Innosys Co., Ltd..

What is the FDA product code for ANAX 5.5 Spinal System?

The FDA product code for ANAX 5.5 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 Innosys Co., Ltd.

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Related Devices (Code: NKB)

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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.