FDA 510(k) Application Details - K213124

Device Classification Name	More FDA Info for this Device
510(K) Number	K213124
Device Name	Tomier PerformÖ Reversed Glenoid Cannulated Glenospheres
Applicant	Tornier, Inc. 10801 Nesbitt Ave. South Bloomington, MN 55437 US Other 510(k) Applications for this Company
Contact	Lisa Stahl 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	09/27/2021
Decision Date	10/26/2021
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