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 Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
510(k) Number K254084
Device Name AETOS Shoulder System - CONCELOC Glenoids
Applicant
Smith & Nephew, Inc.
7135 Goodlett Farms Pkwy.
Cordova,  TN  38016
Applicant Contact Cassidy Whipple
Correspondent
Smith & Nephew, Inc.
7135 Goodlett Farms Pkwy.
Cordova,  TN  38016
Correspondent Contact Cassidy Whipple
Regulation Number888.3660
Classification Product Code
KWS  
Subsequent Product Codes
HSD   KWT   PHX   PKC  
Date Received12/18/2025
Decision Date 04/06/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-