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FDA 510(k)

Virage® Navigation System

K-Number: K240647 · 2024-04-05

ApplicantZimvie Spine (Zimmer Biomet Spine, Inc.)
Decision Date2024-04-05
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Virage® Navigation System is a medical device manufactured by Zimvie Spine (Zimmer Biomet Spine, Inc.). It received FDA 510(k) clearance on 2024-04-05 under approval number K240647. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Virage® Navigation System?

Virage® Navigation System is a medical device that received FDA 510(k) clearance on 2024-04-05. It is manufactured by Zimvie Spine (Zimmer Biomet Spine, Inc.). The 510(k) number is K240647.

When was Virage® Navigation System approved by the FDA?

Virage® Navigation System received FDA 510(k) clearance on 2024-04-05, under approval number K240647.

What company makes Virage® Navigation System?

Virage® Navigation System is manufactured by Zimvie Spine (Zimmer Biomet Spine, Inc.).

What is the FDA product code for Virage® Navigation System?

The FDA product code for Virage® Navigation System is OLO.

Related Clinical Trials

NCT07616050 Evaluation of the Impact of Virtual Park on Training Motivation in Adult Patients NOT_YET_RECRUITING NCT07173309 Evaluation of Eye Gaze Sharing in the Operating Room RECRUITING NCT07174479 Eye Gaze Guidance Evaluation in Phantoms COMPLETED NCT06631638 EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN)) RECRUITING NCT07271238 Feasibility Study on the VERAFEYE Imaging and Navigation System for Guided Catheter Ablation Procedures RECRUITING NCT06895187 Catheter Ablation Using a Novel Navigation and Imaging System NOT_YET_RECRUITING

Related PubMed Literature

PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025)

Other Devices by Zimvie Spine (Zimmer Biomet Spine, Inc.)

K233443Vital™ Navigation System K230116Vital™ Spinal Fixation System K240539Vital™ Spinal Fixation System

Related Devices (Code: OLO)

K162375Envision 3D: Image Guidance System7D Surgical, Inc. K162341Stryker OrthoMap Precision Knee systemStryker Leibinger GmbH & Co KG K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc. K160385Precision ScrewCryptych Pty, Ltd. K153700Aesculap(R) Implant Systems (AIS) S4 Navigation InstrumentsAesculap Implant Systems, LLC K153240Styrker OrthoMap Express Knee SystemStryker Corporate

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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