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 K132640
Device Name IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM
Applicant
CONFORMIS, INC.
28 Crosby Dr
Bedford,  MA  01730
Applicant Contact AMITA SHAH
Correspondent
CONFORMIS, INC.
28 Crosby Dr
Bedford,  MA  01730
Correspondent Contact AMITA SHAH
Regulation Number888.3520
Classification Product Code
HSX  
Subsequent Product Code
OOG  
Date Received08/23/2013
Decision Date 12/05/2013
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
-
-