Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MCI-Neuro Fixation System

K-Number: K212391 · 2022-10-21

ApplicantMci Medical Concept Innovation, Inc.
Decision Date2022-10-21
Product CodeGWO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MCI-Neuro Fixation System is a medical device manufactured by Mci Medical Concept Innovation, Inc.. It received FDA 510(k) clearance on 2022-10-21 under approval number K212391. The device is classified under product code GWO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MCI-Neuro Fixation System?

MCI-Neuro Fixation System is a medical device that received FDA 510(k) clearance on 2022-10-21. It is manufactured by Mci Medical Concept Innovation, Inc.. The 510(k) number is K212391.

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

MCI-Neuro Fixation System received FDA 510(k) clearance on 2022-10-21, under approval number K212391.

What company makes MCI-Neuro Fixation System?

MCI-Neuro Fixation System is manufactured by Mci Medical Concept Innovation, Inc..

What is the FDA product code for MCI-Neuro Fixation System?

The FDA product code for MCI-Neuro Fixation System is GWO.

Related Clinical Trials

NCT06727942 Virtual Reality-Infused Treadmill Training on Aging-Related Outcomes RECRUITING NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07277946 AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE RECRUITING NCT06087445 A User-friendly, Non-invasive Neuro-orthosis That Restores Volitionally Controlled Grasp Functions for SCI Survivors With Tetraplegia COMPLETED NCT07033130 The Performance of Different Sound Paths in Adult NeuroZti CI-users TERMINATED NCT07214220 Intravascular Neuro OCT Imaging System for Aneurysm Treatment Evaluation RECRUITING

Other Devices by Mci Medical Concept Innovation, Inc.

K182758MCI - CMF System

Related Devices (Code: GWO)

K161821Stryker Universal MeshStryker K161446Biopor Porous Polyethylene ImplantsCeremed , Inc. K153248PEEK Customized Cranial ImplantStryker K170725Stryker Universal MeshStryker K170368Sterile NS SystemJeil Medical Corporation K182425Universal Mesh - SterileStryker Leibinger GmbH & Co KG

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.

↑