FDA 510(k) Application Details - K142835

Device Classification Name	Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease   More FDA Info for this Device
510(K) Number	K142835
Device Name	Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
Applicant	MEDYSSEY USA, INC. 1550 E. HIGGINS ROAD, SUITE 123 ELK GROVE VILLAGE, IL 60007 US Other 510(k) Applications for this Company
Contact	JOHN KUCZYNSKI Other 510(k) Applications for this Contact
Regulation Number	888.3070   More FDA Info for this Regulation Number
Classification Product Code	NKB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/30/2014
Decision Date	06/12/2015
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