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FDA 510(k)

FORTICO Anterior Cervical Fixation System

K-Number: K191584 · 2019-10-22

ApplicantCamber Spine Technologies, LLC
Decision Date2019-10-22
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FORTICO Anterior Cervical Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Camber Spine Technologies, LLC. It received FDA 510(k) clearance on 2019-10-22 under 510(k) number K191584. 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 FORTICO Anterior Cervical Fixation System?

FORTICO Anterior Cervical Fixation System is a medical device that received FDA 510(k) clearance on 2019-10-22. The listed applicant is Camber Spine Technologies, LLC. The 510(k) number is K191584.

When did FORTICO Anterior Cervical Fixation System receive FDA 510(k) clearance?

FORTICO Anterior Cervical Fixation System received FDA 510(k) clearance on 2019-10-22, under 510(k) number K191584.

Who is the listed applicant for FORTICO Anterior Cervical Fixation System?

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

What is the FDA product code for FORTICO Anterior Cervical Fixation System?

The FDA product code for FORTICO Anterior Cervical Fixation System is KWQ.

Related Clinical Trials

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Other records listing Camber Spine Technologies, 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.

K234077SPIRA® Anterior Lumbar SpacersK232256Alcantara Thoracolumbar Plate SystemK233972Camber Sacroiliac (SI) Fixation SystemK230942SPIRA® Posterior Lumbar SpacersK221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)K223837SPIRA®-C Integrated Fixation System

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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

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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