Device Classification Name |
intervertebral fusion device with bone graft, lumbar
|
510(k) Number |
K191788 |
Device Name |
CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium, DIVERGENCE-L Anterior/Oblique Lumbar Fusion System |
Applicant |
Medtronic Sofamor Danek, USA Inc. |
1800 Pyramid Place |
Memphis,
TN
38132
|
|
Applicant Contact |
Mia Wiggins |
Correspondent |
Medtronic Sofamor Danek, USA Inc. |
1800 Pyramid Place |
Memphis,
TN
38132
|
|
Correspondent Contact |
Mia Wiggins |
Regulation Number | 888.3080
|
Classification Product Code |
|
Date Received | 07/03/2019 |
Decision Date | 03/23/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|