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FDA 510(k)

NuVasive Next Generation NVM5 System

K-Number: K162313 · 2017-03-16

ApplicantNu Vasive, Incorporated
Decision Date2017-03-16
Product CodePDQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

NuVasive Next Generation NVM5 System is a medical device manufactured by Nu Vasive, Incorporated. It received FDA 510(k) clearance on 2017-03-16 under approval number K162313. The device is classified under product code PDQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NuVasive Next Generation NVM5 System?

NuVasive Next Generation NVM5 System is a medical device that received FDA 510(k) clearance on 2017-03-16. It is manufactured by Nu Vasive, Incorporated. The 510(k) number is K162313.

When was NuVasive Next Generation NVM5 System approved by the FDA?

NuVasive Next Generation NVM5 System received FDA 510(k) clearance on 2017-03-16, under approval number K162313.

What company makes NuVasive Next Generation NVM5 System?

NuVasive Next Generation NVM5 System is manufactured by Nu Vasive, Incorporated.

What is the FDA product code for NuVasive Next Generation NVM5 System?

The FDA product code for NuVasive Next Generation NVM5 System is PDQ.

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Other Devices by Nu Vasive, Incorporated

K162138NuVasive CoRoent Small Ti-C System K161014NuVasive® Reline® System K161442NuVasive® CoRoent® Small Interlock™ System K161230NuVasive Lumbar Interbody Implants K161265NuVasive® VersaTie System K153105MLX™ - Medial Lateral Expandable Lumbar Interbody System

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Related Devices (Code: PDQ)

K161893Neuromonitoring KitSI-BONE, Inc. K152747DSG Threaded Drill SystemSpineguard S.A. K152942NuVasiveNVM5 SystemNu Vasive, Incorporated K171807ES2 Neuromonitoring Accessory InstrumentsStryker Corporation K181559Neurosign V4 Intraoperative Nerve MonitorMagstim Company, Ltd. K180542NIM PAK Needle; NIM XPAK Needle; NIM Pedicle ProbeBoston Endo Surgical Tech,

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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