FDA 510(k) Application Details - K050806

Device Classification Name	Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)   More FDA Info for this Device
510(K) Number	K050806
Device Name	Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
Applicant	EXACTECH, INC. 2320 N.W. 66TH CT. GAINESVILLE, FL 32653 US Other 510(k) Applications for this Company
Contact	REBECCA S ROBERTS 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	03/30/2005
Decision Date	02/08/2006
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