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FDA 510(k)

NuVasive Pulse System

K-Number: K180038 · 2018-06-29

Decision Date2018-06-29
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NuVasive Pulse System is a medical device manufactured by Nu Vasive, Incorporated. It received FDA 510(k) clearance on 2018-06-29 under approval number K180038. 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 2018-06-29. It is manufactured by Nu Vasive, Incorporated. The 510(k) number is K180038.

When was NuVasive Pulse System approved by the FDA?

NuVasive Pulse System received FDA 510(k) clearance on 2018-06-29, under approval number K180038.

What company makes NuVasive Pulse System?

NuVasive Pulse System is manufactured by Nu Vasive, Incorporated.

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.