FDA 510(k) Application Details - K183092

Device Classification Name	Intervertebral Fusion Device With Bone Graft, Lumbar   More FDA Info for this Device
510(K) Number	K183092
Device Name	Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant	Kuros Biosciences BV Prof. Bronkhorstlaan 10, building 48 Bilthoven 3723 MB NL Other 510(k) Applications for this Company
Contact	Yvonne P. Bovell 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	11/07/2018
Decision Date	03/08/2019
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