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FDA 510(k)

NuVasive LessRay with Enhanced Tracking

K-Number: K170800 · 2017-08-18

ApplicantNu Vasive, Incorporated
Decision Date2017-08-18
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

NuVasive LessRay with Enhanced Tracking is a medical device manufactured by Nu Vasive, Incorporated. It received FDA 510(k) clearance on 2017-08-18 under approval number K170800. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NuVasive LessRay with Enhanced Tracking?

NuVasive LessRay with Enhanced Tracking is a medical device that received FDA 510(k) clearance on 2017-08-18. It is manufactured by Nu Vasive, Incorporated. The 510(k) number is K170800.

When was NuVasive LessRay with Enhanced Tracking approved by the FDA?

NuVasive LessRay with Enhanced Tracking received FDA 510(k) clearance on 2017-08-18, under approval number K170800.

What company makes NuVasive LessRay with Enhanced Tracking?

NuVasive LessRay with Enhanced Tracking is manufactured by Nu Vasive, Incorporated.

What is the FDA product code for NuVasive LessRay with Enhanced Tracking?

The FDA product code for NuVasive LessRay with Enhanced Tracking is OWB.

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Related PubMed Literature

PMID: 41116086 Eye-tracking-based tablet application for enhanced cognitive assessment: a clinical trial for software as a medical device (SaMD). GeroScience (2025)

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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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