Device Classification Name |
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
|
510(k) Number |
K113327 |
Device Name |
HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) 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 | 11/10/2011 |
Decision Date | 03/29/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|