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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 the device name listed in this FDA 510(k) record. The listed applicant is Mighty Oak Medical, Inc.. It received FDA 510(k) clearance on 2022-10-26 under 510(k) 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. The listed applicant is Mighty Oak Medical, Inc.. The 510(k) number is K220132.

When did FIREFLY® Cervical Navigation Guide receive FDA 510(k) clearance?

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

Who is the listed applicant for FIREFLY® Cervical Navigation Guide?

The FDA 510(k) record lists Mighty Oak Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Mighty Oak Medical, Inc. 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.

K260322Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)K253472FIREFLY® Pedicle Screw Navigation GuideK252103Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)K251532Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)K234009Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)K181883FIREFLY® Midline Navigation Guide

View all 9 devices →

Related Devices (Code: QSD)

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.

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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