Medtronic Sofamor Danek USA, Inc.
FDA 510(k) & PMA Approved Devices — 79 products
Total Devices79
Categories19
Latest FDA decision2026-07-28
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K192336 | Navigated Anterolateral Disc Prep Instruments | OLO | 2019-11-22 | View |
| 510(k) | K190840 | Medtronic Transportation / Sterilization Cassettes | KCT | 2019-10-15 | View |
| 510(k) | K191066 | CD Horizon™ Astute™ Spinal System | NQP | 2019-10-03 | View |
| 510(k) | K191148 | Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw Set | PML | 2019-09-12 | View |
| 510(k) | K191039 | Navigated T2 STRATOSPHERE Inserters and Navigated Templates | OLO | 2019-08-26 | View |
| 510(k) | K190959 | ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with TiONIC Technology | MAX | 2019-07-03 | View |
| 510(k) | K190165 | Capstone Control™ Spinal System | MAX | 2019-05-06 | View |
| 510(k) | K183197 | PYRAMESH™ Implant System | MQP | 2019-04-04 | View |
| 510(k) | K182885 | Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™ Anterior Cervical Plate, Venture™ Anterior Cervical Plate, Zephir™ Anterior Cervical Plate System and Zevo™ Anterior Cervical Plate System | KWQ | 2019-02-06 | View |
| 510(k) | K183510 | T2 STRATOSPHERE Expandable Corpectomy System | MQP | 2019-01-16 | View |
| 510(k) | K182497 | OsteoCool RF Ablation System | GEI | 2019-01-15 | View |
| 510(k) | K182928 | CD Horizon™ Spinal System | NQP | 2019-01-11 | View |
| 510(k) | K182121 | CD HORIZON Spinal System Instruments for use with MAZOR X Stealth Edition | OLO | 2018-11-02 | View |
| 510(k) | K182436 | POWEREASE System | HBE | 2018-10-04 | View |
| 510(k) | K181328 | T2 STRATOSPHERE™ Expandable Corpectomy System | MQP | 2018-09-19 | View |
| 510(k) | K182119 | CD HORIZON™ Spinal System | NKB | 2018-08-29 | View |
| 510(k) | K180700 | KYPHON HV-R Bone Cement | NDN | 2018-05-18 | View |
| 510(k) | K181111 | Navigated INFINITY Instruments | OLO | 2018-05-17 | View |
| 510(k) | K180851 | VERTEX™ Reconstruction System | NKG | 2018-04-18 | View |
| 510(k) | K173249 | CD HORIZON™ Spinal System | NKB | 2018-03-08 | View |
No matching devices.
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