FDA 510(k) Application Details - K093719

Device Classification Name	Screw, Fixation, Intraosseous   More FDA Info for this Device
510(K) Number	K093719
Device Name	Screw, Fixation, Intraosseous
Applicant	OSTEOGENICS BIOMEDICAL, INC. 4620 71ST ST., BLDG. 78-79 LUBBOCK, TX 79424 US Other 510(k) Applications for this Company
Contact	DUSTYN WEBB Other 510(k) Applications for this Contact
Regulation Number	872.4880   More FDA Info for this Regulation Number
Classification Product Code	DZL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/02/2009
Decision Date	03/01/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review