FDA 510(k) Application Details - K092082

Device Classification Name	Screw, Fixation, Bone   More FDA Info for this Device
510(K) Number	K092082
Device Name	Screw, Fixation, Bone
Applicant	SYNERGY SURGICAL TECHNOLOGIES, LLC 11234 EL CAMINO REAL, SUITE 200 SAN DIEGO, CA 92130 US Other 510(k) Applications for this Company
Contact	KEVIN THOMAS Other 510(k) Applications for this Contact
Regulation Number	888.3040   More FDA Info for this Regulation Number
Classification Product Code	HWC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/09/2009
Decision Date	10/02/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review