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 K190577
Device Name World Knee Total Knee Systems
Applicant
Signature Orthopaedics Pty, Ltd.
7 Sirius Rd.
Lane Cove West,  AU 2066
Applicant Contact Declan Brazil
Correspondent
Signature Orthopaedics Pty, Ltd.
7 Sirius Rd.
Lane Cove West,  AU 2066
Correspondent Contact Declan Brazil
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Code
MBH  
Date Received03/06/2019
Decision Date 11/27/2019
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
-
-