Device Classification Name |
intervertebral fusion device with bone graft, lumbar
|
510(k) Number |
K201267 |
Device Name |
Adaptix Interbody System with Titan nanoLOCK Surface Technology |
Applicant |
Medtronic Sofamor Danek |
1800 Pyramid Place |
Memphis,
TN
38132
|
|
Applicant Contact |
Diamond Wallace |
Correspondent |
Medtronic Sofamor Danek |
1800 Pyramid Place |
Memphis,
TN
38132
|
|
Correspondent Contact |
Diamond Wallace |
Regulation Number | 888.3080
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/12/2020 |
Decision Date | 08/26/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|