FDA 510(k) Application Details - K191134

Device Classification Name	Intervertebral Fusion Device With Bone Graft, Lumbar   More FDA Info for this Device
510(K) Number	K191134
Device Name	Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant	Medicrea International S.A. 5389, route de Strasbourg Rillieux-la-Pape 69140 FR Other 510(k) Applications for this Company
Contact	David Ryan 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	04/29/2019
Decision Date	10/30/2019
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