FIREFLY® Pedicle Screw Navigation Guide

Pedicle Screw Placement Guide

MIGHTY OAK MEDICAL INC.

The following data is part of a premarket notification filed by Mighty Oak Medical Inc. with the FDA for Firefly® Pedicle Screw Navigation Guide.

Pre-market Notification Details

• Device ID: K162419
• 510k Number: K162419
• Device Name: FIREFLY® Pedicle Screw Navigation Guide
• Classification: Pedicle Screw Placement Guide
• Applicant: MIGHTY OAK MEDICAL INC. 750 W. HAMPDEN AVENUE SUITE 120 Englewood, CO 80110
• Contact: Mark A. Wylie
• Correspondent: Mark A. Wylie; MIGHTY OAK MEDICAL INC. 750 W. HAMPDEN AVENUE SUITE 120 Englewood, CO 80110
• Product Code: PQC
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-08-30
• Decision Date: 2016-10-28
• Summary: summary