FDA 510(k)

ANAX OCT Spinal System

K-Number: K251725 · 2025-06-25

Decision Date2025-06-25

Product CodeNKG

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

ANAX OCT Spinal System is a medical device manufactured by Cg Medtech Co., Ltd.. It received FDA 510(k) clearance on 2025-06-25 under approval number K251725. The device is classified under product code NKG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANAX OCT Spinal System?

ANAX OCT Spinal System is a medical device that received FDA 510(k) clearance on 2025-06-25. It is manufactured by Cg Medtech Co., Ltd.. The 510(k) number is K251725.

When was ANAX OCT Spinal System approved by the FDA?

ANAX OCT Spinal System received FDA 510(k) clearance on 2025-06-25, under approval number K251725.

What company makes ANAX OCT Spinal System?

ANAX OCT Spinal System is manufactured by Cg Medtech Co., Ltd..

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

The FDA product code for ANAX OCT Spinal System is NKG.

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Related PubMed Literature

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Related Devices (Code: NKG)

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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.