FDA 510(k) Application Details - K141419

Device Classification Name	Cement, Bone, Vertebroplasty   More FDA Info for this Device
510(K) Number	K141419
Device Name	Cement, Bone, Vertebroplasty
Applicant	ZAVATION LLC 400 LIBERTY PARK DR FLOWOOD, MS 39232 US Other 510(k) Applications for this Company
Contact	JOHN WALKER 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	05/29/2014
Decision Date	09/12/2014
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