FDA 510(k) Application Details - K092076

Device Classification Name	Orthosis, Spinal Pedicle Fixation   More FDA Info for this Device
510(K) Number	K092076
Device Name	Orthosis, Spinal Pedicle Fixation
Applicant	CORENTEC CO., LTD 1129 BLOOMFIELD AVE WEST CALDWELL, NJ 07006 US Other 510(k) Applications for this Company
Contact	ROBERT SCHIFF 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	07/09/2009
Decision Date	04/02/2010
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