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 K163167
Device Name CKS Plus Knee System
Applicant
Consensus Orthopedics, Inc.
1115 Windfield Way
El Dorado Hills,  CA  95762
Applicant Contact ZAC JOHNSON
Correspondent
Consensus Orthopedics, Inc.
1115 Windfield Way
El Dorado Hills,  CA  95762
Correspondent Contact ZAC JOHNSON
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Code
OIY  
Date Received11/14/2016
Decision Date 08/09/2017
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
-
-