Device Classification Name |
Appliance, Fixation, Spinal Intervertebral Body
|
510(k) Number |
K121658 |
Device Name |
ORTHOFIX ACP (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 | 06/05/2012 |
Decision Date | 07/20/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|