FDA 510(k) Application Details - K101288

Device Classification Name	Spinal Vertebral Body Replacement Device   More FDA Info for this Device
510(K) Number	K101288
Device Name	Spinal Vertebral Body Replacement Device
Applicant	SPINE WAVE, INC. THREE ENTERPRISE DR. SUITE 210 SHELTON, CT 06484 US Other 510(k) Applications for this Company
Contact	ROAIDA RIZKALLAH Other 510(k) Applications for this Contact
Regulation Number	888.3060   More FDA Info for this Regulation Number
Classification Product Code	MQP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/07/2010
Decision Date	09/10/2010
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