FDA 510(k) Application Details - K041989

Device Classification Name	Appliance, Fixation, Spinal Intervertebral Body   More FDA Info for this Device
510(K) Number	K041989
Device Name	Appliance, Fixation, Spinal Intervertebral Body
Applicant	SINTEA BIOTECH, INC. 407 LINCOLN RD. SUITE 10L MIAMI BEACH, FL 33139 US Other 510(k) Applications for this Company
Contact	ISABELLA ELIAS 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	07/23/2004
Decision Date	09/16/2004
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