FDA 510(k) Application Details - K181140

Device Classification Name	Intervertebral Fusion Device With Bone Graft, Cervical   More FDA Info for this Device
510(K) Number	K181140
Device Name	Intervertebral Fusion Device With Bone Graft, Cervical
Applicant	Axis Orthopaedics 34355 Poppy Wood St. Soldotna, AK 99669 US Other 510(k) Applications for this Company
Contact	Craig Wilcox Other 510(k) Applications for this Contact
Regulation Number	888.3080   More FDA Info for this Regulation Number
Classification Product Code	ODP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/30/2018
Decision Date	11/16/2018
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