FDA 510(k)

Virage® OCT Spinal Fixation System

K-Number: K250332 · 2025-04-04

Decision Date2025-04-04

Product CodeNKG

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Virage® OCT Spinal Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Highridge Medical, LLC. It received FDA 510(k) clearance on 2025-04-04 under 510(k) number K250332. 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 Virage® OCT Spinal Fixation System?

Virage® OCT Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2025-04-04. The listed applicant is Highridge Medical, LLC. The 510(k) number is K250332.

When did Virage® OCT Spinal Fixation System receive FDA 510(k) clearance?

Virage® OCT Spinal Fixation System received FDA 510(k) clearance on 2025-04-04, under 510(k) number K250332.

Who is the listed applicant for Virage® OCT Spinal Fixation System?

The FDA 510(k) record lists Highridge Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Virage® OCT Spinal Fixation System?

The FDA product code for Virage® OCT Spinal Fixation System is NKG.

Other records listing Highridge Medical, LLC 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.

PMA P110009Prosthesis, intervertebral disc PMA P110002Prosthesis, intervertebral disc PMA P120024Prosthesis, intervertebral disc K253093Vital™ Spinal Fixation System

Related Devices (Code: NKG)

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 AG K253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.K251725ANAX™ OCT Spinal SystemCg Medtech Co., Ltd.

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.