FDA 510(k) Application Details - K143572

Device Classification Name	Intervertebral Fusion Device With Bone Graft, Cervical   More FDA Info for this Device
510(K) Number	K143572
Device Name	Intervertebral Fusion Device With Bone Graft, Cervical
Applicant	Osteomed Implantes, LTDA Washington Luiz Road, km 172, Condominio Conpark - Rua 6 Rio Claro 13501-600 BR Other 510(k) Applications for this Company
Contact	Niderdani Ragonha Other 510(k) Applications for this Contact
Regulation Number	888.3080   More FDA Info for this Regulation Number
Classification Product Code	ODP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/17/2014
Decision Date	06/10/2015
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