Device Classification Name |
prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
|
510(k) Number |
K122232 |
Device Name |
GMK NARROW |
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 | 07/26/2012 |
Decision Date | 09/28/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|