| Device Classification Name |
prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
|
|---|
| 510(K) Number |
K120790 |
|---|
| Model |
VARIOUS (PART NUMBERS INCLUDED IN SUBMISSION)
|
| Device Name |
GMK - LINE EXTENSION |
|---|
| Applicant |
| MEDACTA INTERNATIONAL |
| 4725 calle quetzal, unit b |
|
camarillo,
CA
93012
|
|
| Contact |
adam gross |
| Regulation Number | 888.3560
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 03/15/2012 |
|---|
| Decision Date | 06/08/2012 |
|---|
| Decision |
substantially equivalent (SE) |
|---|
| Classification Advisory Committee |
Orthopedic
|
|---|
| Review Advisory Committee |
Orthopedic
|
|---|
| summary |
summary
|
| Type |
Special
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
|
|
