FDA 510(k) Application Details - K192076

Device Classification Name	Appliance, Fixation, Spinal Intervertebral Body   More FDA Info for this Device
510(K) Number	K192076
Device Name	Appliance, Fixation, Spinal Intervertebral Body
Applicant	Genesys Spine 1250 South Capital of Texas Highway, Building 3 Suite 600 Austin, TX 78746 US Other 510(k) Applications for this Company
Contact	Andrew C. Davison C. Davison Other 510(k) Applications for this Contact
Regulation Number	888.3060   More FDA Info for this Regulation Number
Classification Product Code	KWQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/02/2019
Decision Date	08/29/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review