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, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
510(k) Number K212129
Device Name Persona® Personalized Knee System
Applicant
Zimmer Switzerland Manufacturing GmbH
Sulzer Allee 8
Winterthur,  CH 8404
Applicant Contact Thomas Lincoln
Correspondent
Zimmer Switzerland Manufacturing GmbH
Sulzer Allee 8
Winterthur,  CH 8404
Correspondent Contact Anne-Kathrin Born
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Codes
MBH   OIY  
Date Received07/08/2021
Decision Date 09/28/2021
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
-
-