Device Classification Name |
Appliance, Fixation, Spinal Intervertebral Body
|
510(k) Number |
K130825 |
Device Name |
AZURE ANTERIOR CERVICAL PLATE SYSTEM |
Applicant |
ORTHOFIX, INC. |
3451 PLANO PARKWAY |
LEWISVILLE,
TX
75056
|
|
Applicant Contact |
ALLY BADUEL |
Correspondent |
ORTHOFIX, INC. |
3451 PLANO PARKWAY |
LEWISVILLE,
TX
75056
|
|
Correspondent Contact |
ALLY BADUEL |
Regulation Number | 888.3060
|
Classification Product Code |
|
Date Received | 03/26/2013 |
Decision Date | 05/07/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|