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FDA 510(k)

FIREFLY® Cervical Navigation Guide

K-Number: K220132 · 2022-10-26

ApplicantMighty Oak Medical, Inc.
Decision Date2022-10-26
Product CodeQSD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FIREFLY® Cervical Navigation Guide is a medical device manufactured by Mighty Oak Medical, Inc.. It received FDA 510(k) clearance on 2022-10-26 under approval number K220132. The device is classified under product code QSD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIREFLY® Cervical Navigation Guide?

FIREFLY® Cervical Navigation Guide is a medical device that received FDA 510(k) clearance on 2022-10-26. It is manufactured by Mighty Oak Medical, Inc.. The 510(k) number is K220132.

When was FIREFLY® Cervical Navigation Guide approved by the FDA?

FIREFLY® Cervical Navigation Guide received FDA 510(k) clearance on 2022-10-26, under approval number K220132.

What company makes FIREFLY® Cervical Navigation Guide?

FIREFLY® Cervical Navigation Guide is manufactured by Mighty Oak Medical, Inc..

What is the FDA product code for FIREFLY® Cervical Navigation Guide?

The FDA product code for FIREFLY® Cervical Navigation Guide is QSD.

Related Clinical Trials

NCT06940752 VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters ENROLLING_BY_INVITATION NCT07173309 Evaluation of Eye Gaze Sharing in the Operating Room RECRUITING NCT07174479 Eye Gaze Guidance Evaluation in Phantoms COMPLETED NCT07593872 XR-Assisted PET/CT Navigation for Cervical Lymph Node Dissection in Lung Cancer NOT_YET_RECRUITING NCT07271238 Feasibility Study on the VERAFEYE Imaging and Navigation System for Guided Catheter Ablation Procedures RECRUITING NCT07210151 Anatomical Navigation for Guided Electrophysiology in AFL and AFib RECRUITING

Other Devices by Mighty Oak Medical, Inc.

K162419FIREFLY® Pedicle Screw Navigation Guide K181883FIREFLY® Midline Navigation Guide K181399FIREFLY® Pedicle Screw Navigation Guide

Related Devices (Code: QSD)

K231515MySpine Cervical GuidesMedacta International S.A.

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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