FDA 510(k) Application Details - K140550

Device Classification Name	More FDA Info for this Device
510(K) Number	K140550
Device Name	ORTHOHUB EXTERNAL FIXATOR SOFTWARE
Applicant	ORTHOHUB, INC. 999 MENLO OAKS DRIVE MENLO PARK, CA 94025 US Other 510(k) Applications for this Company
Contact	PEGGY MCLAUGHLIN Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OSN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/04/2014
Decision Date	08/25/2014
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