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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 the device name listed in this FDA 510(k) record. The listed applicant is Nu Vasive, Incorporated. It received FDA 510(k) clearance on 2018-11-28 under 510(k) 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. The listed applicant is Nu Vasive, Incorporated. The 510(k) number is K180498.

When did NuVasive Reline Fenestrated Screws, High V+ Bone Cement receive FDA 510(k) clearance?

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

Who is the listed applicant for NuVasive Reline Fenestrated Screws, High V+ Bone Cement?

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 Reline Fenestrated Screws, High V+ Bone Cement?

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

Other records listing Nu Vasive, Incorporated as applicant

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.

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: PML)

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.

K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura MedicalK241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone CementUlrich Medical USAK230774PERLA® TL System; TEKTONA® HV US Bone CementSpineartK222789VADER® Pedicle System, G21 CementIcotec AG

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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