FDA 510(k) Application Details - K070351

Device Classification Name	Cement, Bone, Vertebroplasty   More FDA Info for this Device
510(K) Number	K070351
Device Name	Cement, Bone, Vertebroplasty
Applicant	DFINE, INC. 19450 STEVENS CREEK BLVD. SUITE 100 CUPERTINO, CA 95014 US Other 510(k) Applications for this Company
Contact	ROBERT POSER 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	02/06/2007
Decision Date	06/29/2007
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