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 Number | 888.3560
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/30/2012 |
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
|
|
|