Device Classification Name |
Plate, Fixation, Bone
|
510(k) Number |
K092671 |
Device Name |
VARIAX ELBOW SYSTEM LINE EXTENSION |
Applicant |
HOWMEDICA OSTEONICS CORP. |
325 Corporate Drive |
Mahwah,
NJ
07430
|
|
Applicant Contact |
MELISSA A MATARESE |
Correspondent |
HOWMEDICA OSTEONICS CORP. |
325 Corporate Drive |
Mahwah,
NJ
07430
|
|
Correspondent Contact |
MELISSA A MATARESE |
Regulation Number | 888.3030
|
Classification Product Code |
|
Date Received | 08/31/2009 |
Decision Date | 09/23/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|