FDA 510(k) Application Details - K081817

Device Classification Name	Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)   More FDA Info for this Device
510(K) Number	K081817
Device Name	Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
Applicant	ISOTIS ORTHOBIOLOGICS, INC 311 ENTERPRISE DRIVE PLAINSBORO, NJ 08536 US Other 510(k) Applications for this Company
Contact	JUDITH E O'GRADY Other 510(k) Applications for this Contact
Regulation Number	888.3045   More FDA Info for this Regulation Number
Classification Product Code	MBP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/26/2008
Decision Date	09/24/2008
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