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FDA 510(k)

Mediant Anterior Cervical Plating System

K-Number: K173935 · 2018-04-16

ApplicantIntelligent Implant Systems, LLC
Decision Date2018-04-16
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Mediant Anterior Cervical Plating System is a medical device manufactured by Intelligent Implant Systems, LLC. It received FDA 510(k) clearance on 2018-04-16 under approval number K173935. 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 Mediant Anterior Cervical Plating System?

Mediant Anterior Cervical Plating System is a medical device that received FDA 510(k) clearance on 2018-04-16. It is manufactured by Intelligent Implant Systems, LLC. The 510(k) number is K173935.

When was Mediant Anterior Cervical Plating System approved by the FDA?

Mediant Anterior Cervical Plating System received FDA 510(k) clearance on 2018-04-16, under approval number K173935.

What company makes Mediant Anterior Cervical Plating System?

Mediant Anterior Cervical Plating System is manufactured by Intelligent Implant Systems, LLC.

What is the FDA product code for Mediant Anterior Cervical Plating System?

The FDA product code for Mediant Anterior Cervical Plating System is KWQ.

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Other Devices by Intelligent Implant Systems, LLC

K160216Revolution Spinal Fixation System K163056Revolution™ Spinal Fixation System

Related Devices (Code: KWQ)

K160982Sphynx™Eden 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

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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