FDA 510(k) Application Details - K122533

Device Classification Name	Cement, Bone, Vertebroplasty   More FDA Info for this Device
510(K) Number	K122533
Device Name	Cement, Bone, Vertebroplasty
Applicant	OSSEON THERAPEUTICS, INC. 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	08/20/2012
Decision Date	10/23/2012
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