FDA 510(k) Application Details - K130832

Device Classification Name	Staple, Fixation, Bone   More FDA Info for this Device
510(K) Number	K130832
Device Name	Staple, Fixation, Bone
Applicant	ORTHOHELIX SURGICAL DESIGNS, INC. 1065 MEDINA ROAD SUITE 500 MEDINA, OH 44256 US Other 510(k) Applications for this Company
Contact	BRIAN HOCKETT Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	JDR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/26/2013
Decision Date	08/15/2013
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