Device Classification Name |
posterior metal/polymer spinal system, fusion
|
510(k) Number |
K191066 |
Device Name |
CD Horizon™ Astute™ Spinal System |
Applicant |
Medtronic Sofamor Danek, USA Inc. |
1800 Pyramid Place |
Memphis,
TN
38132
|
|
Applicant Contact |
Bhavya Vendra |
Correspondent |
Medtronic Sofamor Danek, USA Inc. |
1800 Pyramid Place |
Memphis,
TN
38132
|
|
Correspondent Contact |
Bhavya Vendra |
Regulation Number | 888.3070
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 04/22/2019 |
Decision Date | 10/03/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|