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FDA 510(k)

NuVaisve® Reline® Cervical System

K-Number: K191553 · 2019-08-14

ApplicantNu Vasive, Incorporated
Decision Date2019-08-14
Product CodeNKG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NuVaisve® Reline® Cervical System is a medical device manufactured by Nu Vasive, Incorporated. It received FDA 510(k) clearance on 2019-08-14 under approval number K191553. The device is classified under product code NKG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NuVaisve® Reline® Cervical System?

NuVaisve® Reline® Cervical System is a medical device that received FDA 510(k) clearance on 2019-08-14. It is manufactured by Nu Vasive, Incorporated. The 510(k) number is K191553.

When was NuVaisve® Reline® Cervical System approved by the FDA?

NuVaisve® Reline® Cervical System received FDA 510(k) clearance on 2019-08-14, under approval number K191553.

What company makes NuVaisve® Reline® Cervical System?

NuVaisve® Reline® Cervical System is manufactured by Nu Vasive, Incorporated.

What is the FDA product code for NuVaisve® Reline® Cervical System?

The FDA product code for NuVaisve® Reline® Cervical System is NKG.

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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: NKG)

K161032neon3™ universal OCT spinal stabilizationUlrich GmbH & Co. KG K162300Reform® POCT SystemPrecision Spine, Inc. K162136CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd. K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc. K161478Xenco Medical Posterior Cervical SystemXenco Medical, LLC K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)

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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