FDA 510(k) Application Details - K181399

Device Classification Name	More FDA Info for this Device
510(K) Number	K181399
Device Name	FIREFLY« Pedicle Screw Navigation Guide
Applicant	Mighty Oak Medical Inc. 750 W. Hampden Avenue, Suite 120 Englewood, CO 80110 US Other 510(k) Applications for this Company
Contact	Mark A. Wylie Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PQC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/29/2018
Decision Date	07/24/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review