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 K120955
Device Name COLUMBUS TOTAL KNEE SYSTEM AS COLUMBUS REVISION KNEE SYSTEM ENDURO KNEE SYSTEM
Applicant
AESCULAP IMPLANT SYSTEMS, LLC
3773 Corporate Parkway
Center Valley,  PA  18034
Applicant Contact KATHY A RACOSKY
Correspondent
AESCULAP IMPLANT SYSTEMS, LLC
3773 Corporate Parkway
Center Valley,  PA  18034
Correspondent Contact KATHY A RACOSKY
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Code
KRO  
Date Received03/30/2012
Decision Date 12/17/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-