Device Classification Name |
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
|
510(k) Number |
K113571 |
Device Name |
GMK RESUFACING PATELLA SIZE 4 |
Applicant |
MEDACTA INTERNATIONAL |
4725 Calle Quetzal, Unit B |
Camarillo,
CA
93012
|
|
Applicant Contact |
ADAM GROSS |
Correspondent |
MEDACTA INTERNATIONAL |
4725 Calle Quetzal, Unit B |
Camarillo,
CA
93012
|
|
Correspondent Contact |
ADAM GROSS |
Regulation Number | 888.3560
|
Classification Product Code |
|
Date Received | 12/02/2011 |
Decision Date | 01/27/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|