Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Shoulder Prosthesis, Reverse Configuration
510(k) Number K112144
Device Name AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROSTHESIS
Applicant
Tornier
161 Rue Lavoisier
Monbonnot Saint Martin,  FR 38334
Applicant Contact SEVERINE BONNETON
Correspondent
Tornier
161 Rue Lavoisier
Monbonnot Saint Martin,  FR 38334
Correspondent Contact SEVERINE BONNETON
Regulation Number888.3660
Classification Product Code
PHX  
Subsequent Product Code
KWS  
Date Received07/26/2011
Decision Date 03/13/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-