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FDA 510(k)

NuVasive Pulse System

K-Number: K243814 · 2025-01-10

ApplicantGlobus Medical, Inc.
Decision Date2025-01-10
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NuVasive Pulse System is a medical device manufactured by Globus Medical, Inc.. It received FDA 510(k) clearance on 2025-01-10 under approval number K243814. 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 NuVasive Pulse System?

NuVasive Pulse System is a medical device that received FDA 510(k) clearance on 2025-01-10. It is manufactured by Globus Medical, Inc.. The 510(k) number is K243814.

When was NuVasive Pulse System approved by the FDA?

NuVasive Pulse System received FDA 510(k) clearance on 2025-01-10, under approval number K243814.

What company makes NuVasive Pulse System?

NuVasive Pulse System is manufactured by Globus Medical, Inc..

What is the FDA product code for NuVasive Pulse System?

The FDA product code for NuVasive Pulse System is OLO.

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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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