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FDA 510(k)

ANAX™ OCT Spinal System

K-Number: K183383 · 2018-12-12

ApplicantU&I Corporation
Decision Date2018-12-12
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 U&I Corporation. It received FDA 510(k) clearance on 2018-12-12 under 510(k) number K183383. 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 2018-12-12. The listed applicant is U&I Corporation. The 510(k) number is K183383.

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

ANAX™ OCT Spinal System received FDA 510(k) clearance on 2018-12-12, under 510(k) number K183383.

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

The FDA 510(k) record lists U&I Corporation 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 U&I Corporation as applicant

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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.K251725ANAX™ OCT Spinal SystemCg Medtech Co., Ltd.

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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