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FDA 510(k)

ANAX™ OCT Spinal System

K-Number: K251725 · 2025-06-25

ApplicantCg Medtech Co., Ltd.
Decision Date2025-06-25
Product CodeNKG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ANAX™ OCT Spinal System is the device name listed in this FDA 510(k) record. The listed applicant is Cg Medtech Co., Ltd.. It received FDA 510(k) clearance on 2025-06-25 under 510(k) 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. The listed applicant is Cg Medtech Co., Ltd.. The 510(k) number is K251725.

When did ANAX™ OCT Spinal System receive FDA 510(k) clearance?

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

Who is the listed applicant for ANAX™ OCT Spinal System?

The FDA 510(k) record lists Cg Medtech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Cg Medtech Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252351UniSpace® TPLIF Cage

Related Devices (Code: NKG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw SystemCarboFix Orthopedics , Ltd.K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AGK253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC

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.

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