Device Classification Name |
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
|
510(k) Number |
K093533 |
Device Name |
ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, VERSION 2.0 |
Applicant |
MATERIALISE N.V. |
15 TECHNOLOGIELAAN |
LEUVEN,
BE
3001
|
|
Applicant Contact |
KARL VOM BERGE |
Correspondent |
MATERIALISE N.V. |
15 TECHNOLOGIELAAN |
LEUVEN,
BE
3001
|
|
Correspondent Contact |
KARL VOM BERGE |
Regulation Number | 888.3565
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/16/2009 |
Decision Date | 02/17/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|