FDA 510(k) Application Details - K170855

Device Classification Name	More FDA Info for this Device
510(K) Number	K170855
Device Name	T-Rex Standalone ALIF
Applicant	SIATS, LLC 6316 E 102nd Street Tulsa, OK 74137 US Other 510(k) Applications for this Company
Contact	Robert Compton Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OVD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/22/2017
Decision Date	09/07/2017
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