FDA 510(k) Application Details - K081631

Device Classification Name	Orthosis, Spondyloisthesis Spinal Fixation   More FDA Info for this Device
510(K) Number	K081631
Device Name	Orthosis, Spondyloisthesis Spinal Fixation
Applicant	SINTEA BIOTECH, INC. 407 LINCOLN RD. SUITE 10L MIAMI BEACH, FL 33139 US Other 510(k) Applications for this Company
Contact	DANIELLE WERNIKOWSKI Other 510(k) Applications for this Contact
Regulation Number	888.3070   More FDA Info for this Regulation Number
Classification Product Code	MNH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/11/2008
Decision Date	07/18/2008
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