FDA 510(k) Application Details - K132852

Device Classification Name	Intervertebral Fusion Device With Bone Graft, Lumbar   More FDA Info for this Device
510(K) Number	K132852
Device Name	Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant	NEOORTHO PRODUTOS ORTOPEDICOS S/A 18851 NE 29TH AVE 720 AVENTURA, FL 33180 US Other 510(k) Applications for this Company
Contact	TARA CONRAD Other 510(k) Applications for this Contact
Regulation Number	888.3080   More FDA Info for this Regulation Number
Classification Product Code	MAX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/11/2013
Decision Date	05/29/2014
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