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FDA 510(k)

NuVasive(r) Monolith Corpectomy System

K-Number: K170271 · 2017-03-30

ApplicantNu Vasive, Incorporated
Decision Date2017-03-30
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NuVasive(r) Monolith Corpectomy 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 2017-03-30 under 510(k) number K170271. The device is classified under product code MQP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NuVasive(r) Monolith Corpectomy System?

NuVasive(r) Monolith Corpectomy System is a medical device that received FDA 510(k) clearance on 2017-03-30. The listed applicant is Nu Vasive, Incorporated. The 510(k) number is K170271.

When did NuVasive(r) Monolith Corpectomy System receive FDA 510(k) clearance?

NuVasive(r) Monolith Corpectomy System received FDA 510(k) clearance on 2017-03-30, under 510(k) number K170271.

Who is the listed applicant for NuVasive(r) Monolith Corpectomy 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(r) Monolith Corpectomy System?

The FDA product code for NuVasive(r) Monolith Corpectomy System is MQP.

Other records listing Nu Vasive, Incorporated as applicant

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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: MQP)

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.

K261810Vertiwedge® Intraosseous SystemFoundation Surgical GroupK261031POSEIDON STSignus Medinzintechnik GmbHK253158VyBrate™ VBR SystemVy Spine, LLCK241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AGK233359DOMINION Expandable Corpectomy SystemAstura Medical

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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