Device Classification Name |
Intervertebral Fusion Device With Bone Graft, Cervical
|
510(k) Number |
K172437 |
Device Name |
CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer System |
Applicant |
Orthofix Inc. |
3451 Plano Parkway |
Lewisville,
TX
75056
|
|
Applicant Contact |
Natalia Volosen |
Correspondent |
Orthofix Inc. |
3451 Plano Parkway |
Lewisville,
TX
75056
|
|
Correspondent Contact |
Natalia Volosen |
Regulation Number | 888.3080
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 08/11/2017 |
Decision Date | 11/02/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|