| Device Classification Name |
plate, fixation, bone
|
|---|
| 510(K) Number |
K122737 |
|---|
| Model |
NARROW 3 HOLE, RIGHT AND LEFT, NARROW 4 HOLE, RIGHT AND LIGHT, STANDARD 3 HOLE, RIGHT AND LEFT, STANDARD 4 HOLE, RIGHT
|
| Device Name |
GEMINUS FOSSA SPECIFIC PLATE SYSTEM |
|---|
| Applicant |
| SKELETAL DYNAMICS, LLC |
| 8905 sw 87 avenue, suite 201 |
|
miami,
FL
33176
|
|
| Contact |
ana m escagedo |
| Regulation Number | 888.3030
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 09/06/2012 |
|---|
| Decision Date | 10/03/2012 |
|---|
| 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
|
|---|
|
|
