Cleared Traditional

FIREFLY? Pedicle Screw Navigation Guide

K162419 · Mighty Oak Medical, Inc. · Orthopedic

Oct 2016

Decision

59d

Days

Class 2

Risk

About This 510(k) Submission

K162419 is an FDA 510(k) clearance for the FIREFLY? Pedicle Screw Navigation Guide, a Pedicle Screw Placement Guide (Class II — Special Controls, product code PQC), submitted by Mighty Oak Medical, Inc. (Englewood, US). The FDA issued a Cleared decision on October 28, 2016, 59 days after receiving the submission on August 30, 2016. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K162419 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 30, 2016
Decision Date	October 28, 2016
Days to Decision	59 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	PQC — Pedicle Screw Placement Guide
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3070
Definition	A Pedicle Screw Placement Guide Is Intended To Be Used As A Surgical Instrument To Assist In The Intra-operative Placement Of Pedicle Screws That Are Used To Anchor Pedicle Screw Spinal Systems Onto The Posterior Elements Of The Spine. The Device Utilizes Anatomic Landmarks That Are Identifiable On Pre-operative Imaging Scans.