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 K241609
Device Name Tornier Humeral Reconstruction System (Tornier HRS)
Applicant
Stryker Corporation (Tornier, Inc.)
10801 Nesbitt Ave. S.
Bloomington,  MN  55437
Applicant Contact Jang Long
Correspondent
Stryker Corporation (Tornier, Inc.)
10801 Nesbitt Ave. S.
Bloomington,  MN  55437
Correspondent Contact Jang Long
Regulation Number888.3660
Classification Product Code
KWS  
Subsequent Product Codes
HSD   PHX  
Date Received06/05/2024
Decision Date 09/10/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-