Device Classification Name |
Plate, Bone
|
510(k) Number |
K121574 |
Device Name |
SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM |
Applicant |
SYNTHES INC |
1301 Goshen Parkway |
West Chester,
PA
19380
|
|
Applicant Contact |
ALAN T HALEY |
Correspondent |
SYNTHES INC |
1301 Goshen Parkway |
West Chester,
PA
19380
|
|
Correspondent Contact |
ALAN T HALEY |
Regulation Number | 872.4760
|
Classification Product Code |
|
Date Received | 05/30/2012 |
Decision Date | 06/29/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|