Device Classification Name |
Intervertebral Fusion Device With Bone Graft, Lumbar
|
510(k) Number |
K210425 |
Device Name |
Catalyft PL Expandable Interbody System |
Applicant |
Medtronic Sofamor Danek, USA Inc. |
1800 Pyramid Place |
Memphis,
TN
38132
|
|
Applicant Contact |
Alex Underberg |
Correspondent |
Medtronic Sofamor Danek, USA Inc. |
1800 Pyramid Place |
Memphis,
TN
38132
|
|
Correspondent Contact |
Alex Underberg |
Regulation Number | 888.3080
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/11/2021 |
Decision Date | 05/24/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|