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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 the device name listed in this FDA 510(k) record. The listed applicant is Intelligent Implant Systems, LLC. It received FDA 510(k) clearance on 2018-04-16 under 510(k) 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. The listed applicant is Intelligent Implant Systems, LLC. The 510(k) number is K173935.

When did Mediant Anterior Cervical Plating System receive FDA 510(k) clearance?

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

Who is the listed applicant for Mediant Anterior Cervical Plating System?

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

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

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

Other records listing Intelligent Implant Systems, 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.

K163056Revolution™ Spinal Fixation SystemK160216Revolution Spinal Fixation 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

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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