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FDA 510(k)

NuVasive Reline Fenestrated Screws, High V+ Bone Cement

K-Number: K180498 · 2018-11-28

ApplicantNu Vasive, Incorporated
Decision Date2018-11-28
Product CodePML
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NuVasive Reline Fenestrated Screws, High V+ Bone Cement is a medical device manufactured by Nu Vasive, Incorporated. It received FDA 510(k) clearance on 2018-11-28 under approval number K180498. The device is classified under product code PML. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NuVasive Reline Fenestrated Screws, High V+ Bone Cement?

NuVasive Reline Fenestrated Screws, High V+ Bone Cement is a medical device that received FDA 510(k) clearance on 2018-11-28. It is manufactured by Nu Vasive, Incorporated. The 510(k) number is K180498.

When was NuVasive Reline Fenestrated Screws, High V+ Bone Cement approved by the FDA?

NuVasive Reline Fenestrated Screws, High V+ Bone Cement received FDA 510(k) clearance on 2018-11-28, under approval number K180498.

What company makes NuVasive Reline Fenestrated Screws, High V+ Bone Cement?

NuVasive Reline Fenestrated Screws, High V+ Bone Cement is manufactured by Nu Vasive, Incorporated.

What is the FDA product code for NuVasive Reline Fenestrated Screws, High V+ Bone Cement?

The FDA product code for NuVasive Reline Fenestrated Screws, High V+ Bone Cement is PML.

Related Clinical Trials

NCT07408726 Monoaxial vs. Polyaxial Percutaneous Hybrid Stabilization NOT_YET_RECRUITING

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: PML)

K160879CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw SystemsMedos International Sàrl K152604KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated K171938KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw SetMedtronic K172269FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO® Fenestrated Screw System, REVLOK® Fenestrated Screw SystemGlobus Medical, Inc. K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics , Ltd. K191148Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, 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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