FDA 510(k) Application Details - K110998

Device Classification Name	Cement, Bone, Vertebroplasty   More FDA Info for this Device
510(K) Number	K110998
Device Name	Cement, Bone, Vertebroplasty
Applicant	ALGEA THERAPIES 2560 GENERAL ARMISTEAD AVENUE AUDUBON, PA 19403 US Other 510(k) Applications for this Company
Contact	KELLY J BAKER 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	04/11/2011
Decision Date	10/25/2011
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