FDA 510(k) Application Details - K143222

Device Classification Name	Orthosis, Spinal Pedicle Fixation   More FDA Info for this Device
510(K) Number	K143222
Device Name	Orthosis, Spinal Pedicle Fixation
Applicant	Mighty Oak Medical Inc 777 E Girard Ave. STE 150 Englewood, CO 80113 US Other 510(k) Applications for this Company
Contact	Heidi Frey Other 510(k) Applications for this Contact
Regulation Number	888.3070   More FDA Info for this Regulation Number
Classification Product Code	MNI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/10/2014
Decision Date	12/11/2015
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