Device Classification Name |
plate, fixation, bone
|
510(k) Number |
K100676 |
Device Name |
SYNTHES TOMOFIX(TM) MEIAL HIGH TIBIA PLATE, SMALL |
Applicant |
SYNTHES (USA) |
1301 GOSHEN PKWY. |
WEST CHESTER,
PA
19380
|
|
Applicant Contact |
KARL J NITTINGER |
Correspondent |
SYNTHES (USA) |
1301 GOSHEN PKWY. |
WEST CHESTER,
PA
19380
|
|
Correspondent Contact |
KARL J NITTINGER |
Regulation Number | 888.3030
|
Classification Product Code |
|
Date Received | 03/10/2010 |
Decision Date | 04/08/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|