Cleared Traditional

FIREFLY Pedicle Screw Navigation Guide

K143222 · Mighty Oak Medical, Inc. · Orthopedic
Dec 2015
Decision
396d
Days
Class 2
Risk

About This 510(k) Submission

K143222 is an FDA 510(k) clearance for the FIREFLY Pedicle Screw Navigation Guide, a Orthosis, Spinal Pedicle Fixation (Class II — Special Controls, product code MNI), submitted by Mighty Oak Medical, Inc. (Englewood, US). The FDA issued a Cleared decision on December 11, 2015, 396 days after receiving the submission on November 10, 2014. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number K143222 FDA.gov
FDA Decision Cleared SESE
Date Received November 10, 2014
Decision Date December 11, 2015
Days to Decision 396 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MNI — Orthosis, Spinal Pedicle Fixation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3070

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