Device Classification Name |
prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
|
510(k) Number |
K091263 |
Device Name |
ZIMMER PATIENT SPECIFIC INSTRUMENTS, ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER, MODEL 1.1 (4.3.0.35) |
Applicant |
MATERIALISE N.V. |
15 TECHNOLOGIELAAN |
LEUVEN,
BE
3001
|
|
Applicant Contact |
KARL VON BERGE |
Correspondent |
MATERIALISE N.V. |
15 TECHNOLOGIELAAN |
LEUVEN,
BE
3001
|
|
Correspondent Contact |
KARL VON BERGE |
Regulation Number | 888.3560
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/30/2009 |
Decision Date | 11/19/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|