FDA 510(k) Application Details - K100618

Device Classification Name	Plate, Fixation, Bone   More FDA Info for this Device
510(K) Number	K100618
Device Name	Plate, Fixation, Bone
Applicant	ORTHOHELIX SURGICAL DESIGNS, INC. 1065 MEDINA ROAD SUITE 500 MEDINA, OH 44256 US Other 510(k) Applications for this Company
Contact	DEREK LEWIS Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	HRS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/04/2010
Decision Date	04/20/2010
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