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FDA 510(k)

NuVasive Reline Cervical System

K-Number: K221388 · 2022-09-09

ApplicantNu Vasive, Incorporated
Decision Date2022-09-09
Product CodeNKG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NuVasive Reline Cervical System is a medical device manufactured by Nu Vasive, Incorporated. It received FDA 510(k) clearance on 2022-09-09 under approval number K221388. 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 NuVasive Reline Cervical System?

NuVasive Reline Cervical System is a medical device that received FDA 510(k) clearance on 2022-09-09. It is manufactured by Nu Vasive, Incorporated. The 510(k) number is K221388.

When was NuVasive Reline Cervical System approved by the FDA?

NuVasive Reline Cervical System received FDA 510(k) clearance on 2022-09-09, under approval number K221388.

What company makes NuVasive Reline Cervical System?

NuVasive Reline Cervical System is manufactured by Nu Vasive, Incorporated.

What is the FDA product code for NuVasive Reline Cervical System?

The FDA product code for NuVasive Reline Cervical System is NKG.

Related Clinical Trials

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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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