FDA 510(k) Application Details - K181295

Device Classification Name	More FDA Info for this Device
510(K) Number	K181295
Device Name	Genesys Spine AIS-C Cervical Stand-Alone System
Applicant	Genesys Spine 1250 Capital of Texas Highway South Building 3 Suite 600 Austin, TX 78746 US Other 510(k) Applications for this Company
Contact	Benjamin V. Keller Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OVE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/16/2018
Decision Date	08/29/2018
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