Device Classification Name |
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
|
510(k) Number |
K071499 |
Device Name |
COLUMBUS TOTAL KNEE SYSTEM MIOS CR/PS TIBIAL TRAY |
Applicant |
AESCULAP IMPLANT SYSTEMS, INC. |
3773 CORPORATE PKWY. |
CENTER VALLEY,
PA
18034
|
|
Applicant Contact |
KATHY A RACOSKY |
Correspondent |
AESCULAP IMPLANT SYSTEMS, INC. |
3773 CORPORATE PKWY. |
CENTER VALLEY,
PA
18034
|
|
Correspondent Contact |
KATHY A RACOSKY |
Regulation Number | 888.3560
|
Classification Product Code |
|
Date Received | 05/31/2007 |
Decision Date | 09/14/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|