FDA 510(k) Application Details - K120739

Device Classification Name

  More FDA Info for this Device
510(K) Number K120739
Device Name AEQUALIS ADJUSTABLE MODULAR REVERSE SHOULDER SYSTEM
Applicant TORNIER, INC.
7701 FRANCE AVE SOUTH
SUITE 600
EDINA, MN 55435 US
Other 510(k) Applications for this Company
Contact BRAHIM HADRI
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 03/12/2012
Decision Date 07/05/2012
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



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact