FDA 510(k) Application Details - K101030

Device Classification Name	Screw, Fixation, Bone   More FDA Info for this Device
510(K) Number	K101030
Device Name	Screw, Fixation, Bone
Applicant	BIOPRO, INC. 2929 LAPEER ROAD PORT HURON, MI 48060 US Other 510(k) Applications for this Company
Contact	DAVID MRAK Other 510(k) Applications for this Contact
Regulation Number	888.3040   More FDA Info for this Regulation Number
Classification Product Code	HWC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/13/2010
Decision Date	06/03/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review