Device Classification Name |
prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
|
510(k) Number |
K093806 |
FOIA Releasable 510(k) |
K093806
|
Device Name |
MYKNEE CUTTING BLOCKS |
Applicant |
MEDACTA INTERNATIONAL, SA |
13721 VIA TRES VISTA |
SAN DIEGO,
CA
92129
|
|
Applicant Contact |
NATALIE J KENNEL |
Correspondent |
MEDACTA INTERNATIONAL, SA |
13721 VIA TRES VISTA |
SAN DIEGO,
CA
92129
|
|
Correspondent Contact |
NATALIE J KENNEL |
Regulation Number | 888.3560
|
Classification Product Code |
|
Date Received | 12/11/2009 |
Decision Date | 04/08/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|