FDA 510(k) Application Details - K043355

Device Classification Name	Appliance, Fixation, Spinal Interlaminal   More FDA Info for this Device
510(K) Number	K043355
Device Name	Appliance, Fixation, Spinal Interlaminal
Applicant	SINTEA BIOTECH, INC. 407 LINCOLN RD. SUITE 10L MIAMI BEACH, FL 33139 US Other 510(k) Applications for this Company
Contact	GUIDO ZORZOLI Other 510(k) Applications for this Contact
Regulation Number	888.3050   More FDA Info for this Regulation Number
Classification Product Code	KWP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/06/2004
Decision Date	12/17/2004
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