FDA 510(k) Application Details - K152131

Device Classification Name	Orthosis, Spinal Pedicle Fixation   More FDA Info for this Device
510(K) Number	K152131
Device Name	Orthosis, Spinal Pedicle Fixation
Applicant	Reliance Medical Systems, LLC 545 WEST 500 SOUTH SUITE 100 BOUNTIFUL, UT 84010 US Other 510(k) Applications for this Company
Contact	BRET M BERRY 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	07/31/2015
Decision Date	09/17/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review