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, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
510(k) Number K101206
Device Name TGS UNICOMPARTMENTAL KNEE ARTHROPLASTY (TGS UKA) MODULAR TIBIA SYSTEM
Applicant
ALEXANDRIA RESEARCH TECHNOLOGIES, LLC
13755 FIRST AVENUE NORTH
SUITE 100
PLYMOUTH,  MN  55441
Applicant Contact MICHAEL LARSON
Correspondent
ALEXANDRIA RESEARCH TECHNOLOGIES, LLC
13755 FIRST AVENUE NORTH
SUITE 100
PLYMOUTH,  MN  55441
Correspondent Contact MICHAEL LARSON
Regulation Number888.3520
Classification Product Code
HSX  
Subsequent Product Code
HRY  
Date Received04/30/2010
Decision Date 07/23/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-