FDA 510(k) Application Details - K071857

Device Classification Name	Orthosis, Spinal Pedicle Fixation   More FDA Info for this Device
510(K) Number	K071857
Device Name	Orthosis, Spinal Pedicle Fixation
Applicant	JEMO SPINE, LLC 6170 SOUTH 380 WEST, SUITE 200 MURRAY, UT 84107 US Other 510(k) Applications for this Company
Contact	PATRICK MOORE 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	07/05/2007
Decision Date	08/08/2007
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