MCI-Neuro Fixation System

FDA 510(k) K212391 · Mci Medical Concept Innovation, Inc.

Substantially Equivalent

510(k) numberK212391

Submission

Device name
MCI-Neuro Fixation System
Applicant
Mci Medical Concept Innovation, Inc.
Sunrise, FL, US
Received
August 2, 2021
Decision date
October 21, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GWO – Plate, Cranioplasty, Preformed, Alterable
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5320
Specialty
Neurology
Implant
Yes

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K262874CraniUS PlateGWO · Special CraniUS, LLC09/11/2026SE
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K250297TECHFIT Patient-Specific Cranial SystemGWO · Traditional Techfit Digital Surgery, Inc.10/27/2025SE
K250334Fusion Craniofacial Implant; Fusion Skull ImplantGWO · Traditional Kelyniam Global, Inc.07/25/2025SE
K231834VSP PEEK Cranial ImplantGWO · Traditional 3D Systems, Inc.04/04/2024SE
K210360Neuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models), Neuro…GWO · Traditional Osteonic Co., Ltd.01/27/2022SE
K203055Stryker PEEK Customized Cranial Implant KitGWO · Traditional Stryker02/09/2021SE
K190811Optimus NEURO System - Sterile KitGWO · Traditional Osteonic Co., Ltd.11/27/2019SE
K190229Stryker PEEK Customized Cranial Implant KitGWO · Traditional Stryker07/11/2019SE
K182711Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)GWO · Traditional Kelyniam Global, Inc.05/21/2019SE

More from Kelyniam Global, Inc.

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K182758MCI - CMF SystemJEY · Traditional 12/05/2019SE

Questions and answers

When was MCI-Neuro Fixation System cleared by the FDA?

MCI-Neuro Fixation System (K212391) received a 510(k) decision of Substantially Equivalent on October 21, 2022, 445 days after the submission was received.

What is the product code of K212391?

The FDA product code is GWO – Plate, Cranioplasty, Preformed, Alterable, a Class II (moderate risk) device regulated under 21 CFR 882.5320.