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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 the device name listed in this FDA 510(k) record. The listed applicant is Globus Medical, Inc.. It received FDA 510(k) clearance on 2025-01-10 under 510(k) 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. The listed applicant is Globus Medical, Inc.. The 510(k) number is K243814.

When did NuVasive Pulse System receive FDA 510(k) clearance?

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

Who is the listed applicant for NuVasive Pulse System?

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

What is the FDA product code for NuVasive Pulse System?

The FDA product code for NuVasive Pulse System is OLO.

Related Clinical Trials

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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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