FDA 510(k) Application Details - K162241

Device Classification Name	More FDA Info for this Device
510(K) Number	K162241
Device Name	TITAN 3-DÖ Wedge System
Applicant	PARAGON 28 4B INVERNESS CT.E., STE 280 Englewood, CO 80112 US Other 510(k) Applications for this Company
Contact	Frank S. Bono Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PLF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/10/2016
Decision Date	04/03/2017
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