Device Classification Name |
prosthesis, knee, femorotibial, constrained, cemented, metal/polymer
|
510(k) Number |
K130299 |
Device Name |
GMK HINGE |
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 | 888.3510
|
Classification Product Code |
|
Date Received | 02/07/2013 |
Decision Date | 08/15/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|