FDA 510(k) Application Details - K190684

Device Classification Name	Intervertebral Fusion Device With Bone Graft, Lumbar   More FDA Info for this Device
510(K) Number	K190684
Device Name	Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant	Innovasis, Inc. 614 East 3900 South Salt Lake City, UT 84107 US Other 510(k) Applications for this Company
Contact	Marshall McCarty 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	03/18/2019
Decision Date	06/17/2019
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