Device Classification Name |
appliance, fixation, nail/blade/plate combination, multiple component
|
510(k) Number |
K121252 |
Device Name |
HOFFMANN 3 MODULAR EXTERNAL FIXATION SYSTEM |
Applicant |
STRYKER CORP. |
325 Corporate Drive |
Mahwah,
NJ
07430
|
|
Applicant Contact |
ESTELA CELI |
Correspondent |
STRYKER CORP. |
325 Corporate Drive |
Mahwah,
NJ
07430
|
|
Correspondent Contact |
ESTELA CELI |
Regulation Number | 888.3030
|
Classification Product Code |
|
Date Received | 04/25/2012 |
Decision Date | 07/25/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|