Device Classification Name |
plate, fixation, bone
|
510(k) Number |
K113760 |
Device Name |
VARIAX SUPERIOR AND ANTERIOR, LATERAL AND MIDSHAFT CLAVICLE PLATES VARIAX AIMING BLOCKS & JOYSTICK |
Applicant |
HOWMEDICA OSTEONICS CORP DBA STRYKER ORTHOPAEDICS |
325 Corporate Drive |
Mahwah,
NJ
07430
|
|
Applicant Contact |
VALERIE GIAMBANCO |
Correspondent |
HOWMEDICA OSTEONICS CORP DBA STRYKER ORTHOPAEDICS |
325 Corporate Drive |
Mahwah,
NJ
07430
|
|
Correspondent Contact |
VALERIE GIAMBANCO |
Regulation Number | 888.3030
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/21/2011 |
Decision Date | 04/25/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|