FDA 510(k)

NuVasive® ACP System

K-Number: K201078 · 2020-05-20

Decision Date2020-05-20

Product CodeKWQ

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

NuVasive® ACP System is a medical device manufactured by Nu Vasive, Incorporated. It received FDA 510(k) clearance on 2020-05-20 under approval number K201078. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NuVasive® ACP System?

NuVasive® ACP System is a medical device that received FDA 510(k) clearance on 2020-05-20. It is manufactured by Nu Vasive, Incorporated. The 510(k) number is K201078.

When was NuVasive® ACP System approved by the FDA?

NuVasive® ACP System received FDA 510(k) clearance on 2020-05-20, under approval number K201078.

What company makes NuVasive® ACP System?

NuVasive® ACP System is manufactured by Nu Vasive, Incorporated.

What is the FDA product code for NuVasive® ACP System?

The FDA product code for NuVasive® ACP System is KWQ.

Other Devices by Nu Vasive, Incorporated

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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.