FDA 510(k) Application Details - K091234

Device Classification Name	Cement, Bone, Vertebroplasty   More FDA Info for this Device
510(K) Number	K091234
Device Name	Cement, Bone, Vertebroplasty
Applicant	SKELTEX TECHNOLOGIES, INC. 75 DE MORTAGNE BLVD. BOUCHERVILLE, QUEBEC J4B 6Y4 CA Other 510(k) Applications for this Company
Contact	GEORGE PAPAGIANNIS 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	04/27/2009
Decision Date	02/16/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review