FDA 510(k)

FORTICO Anterior Cervical Fixation System

K-Number: K191584 · 2019-10-22

Decision Date2019-10-22

Product CodeKWQ

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

FORTICO Anterior Cervical Fixation System is a medical device manufactured by Camber Spine Technologies, LLC. It received FDA 510(k) clearance on 2019-10-22 under approval 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. It is manufactured by Camber Spine Technologies, LLC. The 510(k) number is K191584.

When was FORTICO Anterior Cervical Fixation System approved by the FDA?

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

What company makes FORTICO Anterior Cervical Fixation System?

FORTICO Anterior Cervical Fixation System is manufactured by Camber Spine Technologies, LLC.

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

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

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Other Devices by Camber Spine Technologies, LLC

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Related Devices (Code: KWQ)

K160982SphynxEden Spine, LLC K162638CETRA Anterior Cervical Plate SystemOrthofix, Inc. K162194MEDICREA INTERNATIONAL Anterior Cervical Locking Plate SystemMedicrea International SA K162211AccuFit Lateral Plate SystemPrecision Spine, Inc. K162250FortiBridge Anterior Cervical Plate SystemNanovis Spine, LLC K162664Pyrenees Cervical Plate SystemK2m, Inc.

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.