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 K090705
Device Name BALANCED KNEE SYSTEM ULTRACONGRUENT TIBIAL INSERT
Applicant
Ortho Development Corp.
12187 S. Business Park Dr.
Draper,  UT  84020
Applicant Contact JOHANNE YOUNG
Correspondent
Ortho Development Corp.
12187 S. Business Park Dr.
Draper,  UT  84020
Correspondent Contact JOHANNE YOUNG
Regulation Number888.3560
Classification Product Code
JWH  
Date Received03/17/2009
Decision Date 10/09/2009
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
Recalls CDRH Recalls
-
-