• 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 K210551
Device Name Persona Revision Knee System
Zimmer, Inc.
1800 W. Center Street
warsaw,  IN  46580
Applicant Contact romil sheth
Zimmer, Inc.
1800 W. Center Street
warsaw,  IN  46580
Correspondent Contact romil sheth
Regulation Number888.3560
Classification Product Code
Subsequent Product Codes
Date Received02/25/2021
Decision Date 03/18/2021
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Combination Product No