FDA 510(k) Application Details - K183696

Device Classification Name	More FDA Info for this Device
510(K) Number	K183696
Device Name	Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed Glenoid
Applicant	Tornier, Inc. 10801 Nesbitt Avenue South Bloomington, MN 55347 US Other 510(k) Applications for this Company
Contact	Moyees Kamara Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PHX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/31/2018
Decision Date	01/30/2019
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