Device Classification Name |
Intervertebral Fusion Device With Bone Graft, Cervical
|
510(k) Number |
K121649 |
Device Name |
CONSTRUX MINI PEEK TI SPACER SYSTEM |
Applicant |
ORTHOFIX |
3451 PLANO PARKWAY |
LEWISVILLE,
TX
75056
|
|
Applicant Contact |
NATALIA VOLOSEN |
Correspondent |
ORTHOFIX |
3451 PLANO PARKWAY |
LEWISVILLE,
TX
75056
|
|
Correspondent Contact |
NATALIA VOLOSEN |
Regulation Number | 888.3080
|
Classification Product Code |
|
Date Received | 06/05/2012 |
Decision Date | 11/29/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|