FDA 510(k) Application Details - K101704

Device Classification Name	Posterior Metal/Polymer Spinal System, Fusion   More FDA Info for this Device
510(K) Number	K101704
Device Name	Posterior Metal/Polymer Spinal System, Fusion
Applicant	ZIMMER SPINE, INC. 7375 BUSH LAKE RD. MINNEAPOLIS, MN 55439 US Other 510(k) Applications for this Company
Contact	TIM CRABTREE Other 510(k) Applications for this Contact
Regulation Number	888.3070   More FDA Info for this Regulation Number
Classification Product Code	NQP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/17/2010
Decision Date	08/18/2010
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