FDA 510(k) Applications Submitted by KANESHA HINES
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K170679 |
03/06/2017 |
CD HORIZON« Spinal System, Medtronic Reusable Instruments for Use with the IPC« POWEREASE« System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION« and IPC« POWEREASE« Systems |
Medtronic Sofamor Danek |
| K181328 |
05/18/2018 |
T2 STRATOSPHEREÖ Expandable Corpectomy System |
Medtronic Sofamor Danek, USA Inc. |
| K172328 |
08/02/2017 |
SOVEREIGNÖ Spinal System |
Medtronic Sofamor Danek USA, INC |
| K162680 |
09/26/2016 |
SOVEREIGN« Spinal System |
MEDTRONIC SOFAMOR DANEK USA, INC. |
| K173125 |
09/29/2017 |
T2 STRATOSPHEREÖ Expandable Corpectomy System |
Medtronic Sofamor Danek |
| K182885 |
10/15/2018 |
AtlantisÖ Anterior Cervical Plate, DivergenceÖ Anterior Cervical Fusion System, PremierÖ Anterior Cervical Plate, VentureÖ Anterior Cervical Plate, ZephirÖ Anterior Cervical Plate System and ZevoÖ Anterior Cervical Plate System |
Medtronic Sofamor Danek USA, Inc. |
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