Cleared Traditional

FIREFLY? Cervical Navigation Guide

K220132 · Mighty Oak Medical, Inc. · Orthopedic
Oct 2022
Decision
281d
Days
Class 2
Risk

About This 510(k) Submission

K220132 is an FDA 510(k) clearance for the FIREFLY? Cervical Navigation Guide, a Posterior Cervical Screw Placement Guide (Class II — Special Controls, product code QSD), submitted by Mighty Oak Medical, Inc. (Englewood, US). The FDA issued a Cleared decision on October 26, 2022, 281 days after receiving the submission on January 18, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3075.

Submission Details

510(k) Number K220132 FDA.gov
FDA Decision Cleared SESE
Date Received January 18, 2022
Decision Date October 26, 2022
Days to Decision 281 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code QSD — Posterior Cervical Screw Placement Guide
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3075
Definition A Posterior Cervical Screw Placement Guide Is Intended To Be Used As A Surgical Instrument To Assist In The Intra-operative Placement Of Posterior Cervical Screws That Are Used To Anchor Posterior Cervical Screw Systems On The Posterior Elements Of The Spine. The Device Utilizes Anatomic Landmarks That Are Identifiable On Pre-operative Imaging Scans.