FDA 510(k) Application Details - K190885

Device Classification Name	More FDA Info for this Device
510(K) Number	K190885
Device Name	Elevation Spine Saber-C System
Applicant	Elevation Spine 2600 Garden Rd. Suite 330 Monterey, CA 93940 US Other 510(k) Applications for this Company
Contact	Charlie Gilbride 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	04/04/2019
Decision Date	08/07/2019
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