Device Classification Name |
rod, fixation, intramedullary and accessories
|
510(k) Number |
K112059 |
Device Name |
T2 FEMORAL NAIL MODEL 1825-XXXXCP, 1828-XXXXCP |
Applicant |
Stryker |
325 Corporate Drive |
Mahwah,
NJ
07430
|
|
Applicant Contact |
VALERIE GIAMBANCO |
Correspondent |
Stryker |
325 Corporate Drive |
Mahwah,
NJ
07430
|
|
Correspondent Contact |
VALERIE GIAMBANCO |
Regulation Number | 888.3020
|
Classification Product Code |
|
Date Received | 07/19/2011 |
Decision Date | 08/08/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|