Device Classification Name |
orthopedic stereotaxic instrument
|
510(k) Number |
K214011 |
Device Name |
Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal System with Titan nanoLOCK™ Surface Technology Navigated Instruments, and CD Horizon™ Solera™ Voyager™ Spinal System Navigated, Guided, and Powered Drivers |
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 | 882.4560
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/22/2021 |
Decision Date | 02/09/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|