FDA 510(k) Application Details - K112861

Device Classification Name	Appliance, Fixation, Spinal Intervertebral Body   More FDA Info for this Device
510(K) Number	K112861
Device Name	Appliance, Fixation, Spinal Intervertebral Body
Applicant	SINTEA PLUSTEK, LLC 407 LINCOLN ROAD, 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	888.3060   More FDA Info for this Regulation Number
Classification Product Code	KWQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/30/2011
Decision Date	02/24/2012
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