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FDA 510(k)

FortiBridge Anterior Cervical Plate System

K-Number: K162250 · 2016-10-26

ApplicantNanovis Spine, LLC
Decision Date2016-10-26
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FortiBridge Anterior Cervical Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Nanovis Spine, LLC. It received FDA 510(k) clearance on 2016-10-26 under 510(k) number K162250. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FortiBridge Anterior Cervical Plate System?

FortiBridge Anterior Cervical Plate System is a medical device that received FDA 510(k) clearance on 2016-10-26. The listed applicant is Nanovis Spine, LLC. The 510(k) number is K162250.

When did FortiBridge Anterior Cervical Plate System receive FDA 510(k) clearance?

FortiBridge Anterior Cervical Plate System received FDA 510(k) clearance on 2016-10-26, under 510(k) number K162250.

Who is the listed applicant for FortiBridge Anterior Cervical Plate System?

The FDA 510(k) record lists Nanovis Spine, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FortiBridge Anterior Cervical Plate System?

The FDA product code for FortiBridge Anterior Cervical Plate System is KWQ.

Related Clinical Trials

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.

NCT05762055Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative TechnologyENROLLING_BY_INVITATION

Other records listing Nanovis Spine, LLC 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.

K193211Nano FortiFix® System

Related Devices (Code: KWQ)

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.

K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLCK252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd.K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.K260570corra™ cervical plating systemCarlsmed, Inc.K260697VyPlate™ Anterior Cervical Plate SystemVy Spine, LLCK260015ANTERIS Thoracolumbar Plate SystemSpineCraft

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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