Device Classification Name |
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
|
510(k) Number |
K150928 |
Device Name |
Materialise TKA Guide System, Materialise TKA Planner, Materialise TKA Guides |
Applicant |
MATERIALISE N.V. |
TECHNOLOGIELAAN 15 |
LEUVEN,
BE
3001
|
|
Applicant Contact |
Laurel Berzanskis |
Correspondent |
MATERIALISE N.V. |
TECHNOLOGIELAAN 15 |
LEUVEN,
BE
3001
|
|
Correspondent Contact |
Laurel Berzanskis |
Regulation Number | 888.3560
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 04/06/2015 |
Decision Date | 08/10/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|