FDA 510(k) Application Details - K112907

Device Classification Name	Cement, Bone, Vertebroplasty   More FDA Info for this Device
510(K) Number	K112907
Device Name	Cement, Bone, Vertebroplasty
Applicant	MEDOS INTERNATIONAL SARL 325 Paramount Drive Raynham, MA 02767 US Other 510(k) Applications for this Company
Contact	ROBIN DINARDO 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	10/03/2011
Decision Date	12/22/2011
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