FDA 510(k) Application Details - K151143

Device Classification Name	Intervertebral Fusion Device With Bone Graft, Lumbar   More FDA Info for this Device
510(K) Number	K151143
Device Name	Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant	JOIMAX GMBH AMALIENBADSTRASSE 41 Raumfabrik 61 KARLSRUHE 76227 DE Other 510(k) Applications for this Company
Contact	Eulodie Tila 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	04/29/2015
Decision Date	07/09/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review