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 K130143
Device Name PERSONA NATURAL TIBIA BASEPLATES
Applicant
Zimmer, Inc.
P.O. Box 708
Warsaw,  IN  46581
Applicant Contact NICOLE J MEREDITH
Correspondent
Zimmer, Inc.
P.O. Box 708
Warsaw,  IN  46581
Correspondent Contact NICOLE J MEREDITH
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Code
OIY  
Date Received01/22/2013
Decision Date 02/22/2013
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
-
-