FDA 510(k) Application Details - K151553

Device Classification Name	Appliance, Fixation, Spinal Intervertebral Body   More FDA Info for this Device
510(K) Number	K151553
Device Name	Appliance, Fixation, Spinal Intervertebral Body
Applicant	Osteomed Implantes, LTDA Washington Luiz Road, km 172, Condominio Conpark - Rua 6 Rio Claro - SP 13501-600 BR Other 510(k) Applications for this Company
Contact	J.D. WEBB Other 510(k) Applications for this Contact
Regulation Number	888.3060   More FDA Info for this Regulation Number
Classification Product Code	KWQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/09/2015
Decision Date	02/10/2016
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