FDA 510(k) Application Details - K141930

Device Classification Name	Cement, Bone, Vertebroplasty   More FDA Info for this Device
510(K) Number	K141930
Device Name	Cement, Bone, Vertebroplasty
Applicant	OSSEON LLC 2330 CIRCADIAN WAY SANTA ROSA, CA 95407 US Other 510(k) Applications for this Company
Contact	KEITH BURGER Other 510(k) Applications for this Contact
Regulation Number	888.3027   More FDA Info for this Regulation Number
Classification Product Code	NDN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/16/2014
Decision Date	08/21/2014
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