FDA 510(k) Application Details - K211413

Device Classification Name	Intervertebral Fusion Device With Bone Graft, Lumbar   More FDA Info for this Device
510(K) Number	K211413
Device Name	Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant	NGMedical GmbH Talsperrenblick 5 Nonnweiler 66620 DE Other 510(k) Applications for this Company
Contact	Stella Hahn 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	05/06/2021
Decision Date	08/27/2021
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