FDA 510(k) Application Details - K130641

Device Classification Name	More FDA Info for this Device
510(K) Number	K130641
Device Name	LOGIC STAND-ALONE INTERVERTEBRAL BODY FUSION DEVICE
Applicant	BINDER BIOMEDICAL, INC 1951 NW 7TH AVENUE, STE 13135 MIAMI, FL 33136 US Other 510(k) Applications for this Company
Contact	LAWRENCE BINDER Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OVD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/11/2013
Decision Date	09/13/2013
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