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FDA 510(k)

NuVasive® ACP System

K-Number: K191500 · 2019-09-03

ApplicantNu Vasive, Incorporated
Decision Date2019-09-03
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NuVasive® ACP System is the device name listed in this FDA 510(k) record. The listed applicant is Nu Vasive, Incorporated. It received FDA 510(k) clearance on 2019-09-03 under 510(k) number K191500. 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 2019-09-03. The listed applicant is Nu Vasive, Incorporated. The 510(k) number is K191500.

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

NuVasive® ACP System received FDA 510(k) clearance on 2019-09-03, under 510(k) number K191500.

Who is the listed applicant for NuVasive® ACP System?

The FDA 510(k) record lists Nu Vasive, Incorporated as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Nu Vasive, Incorporated as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody System; NuVasive CoRoent Small Interlock System; NuVasive CoRoent Small Interlock II System; NuVasive CoRoent Small Ti-C System; NuVasive Cohere Cervical Interbody SystemK230894NuVasive Modulus ALIF SystemK230989Rod Registration FrameK223181NuVasive Reline SystemK221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceK221388NuVasive Reline Cervical System

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Related Devices (Code: KWQ)

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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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