• 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 K162775
Device Name Legion Cone System
Applicant
Smith & Nephew, Inc.
7135 Goodlett Farms Parkway
cordova,  TN  38016
Applicant Contact natalie williams
Correspondent
Smith & Nephew, Inc.
1450 Brooks Road
memphis,  TN  38116
Correspondent Contact dongeun kim
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Code
MBH  
Date Received10/03/2016
Decision Date 01/13/2017
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-