Medtronic Sofamor Danek USA, Inc.
FDA 510(k) & PMA Approved Devices — 76 products
Total Devices76
Categories19
Latest Approval2026-04-21
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| 510(k) | K260216 | CD Horizon ModuLeX Fenestrated Screw Set; CD Horizon ModuLeX Spinal System | NKB | 2026-04-21 | View |
| 510(k) | K254165 | Infinity OCT System | NKG | 2026-01-21 | View |
| 510(k) | K253941 | CD Horizon ModuLeX Spinal System (LigaMAS Head Assembly) | NKB | 2026-01-07 | View |
| 510(k) | K253129 | Infinity OCT System | NKG | 2025-10-24 | View |
| 510(k) | K253335 | CD Horizon Spinal System | NKB | 2025-10-24 | View |
| 510(k) | K251444 | Endoskeleton Interbody Systems | MAX | 2025-09-04 | View |
| 510(k) | K251395 | The Rialto SI Fusion System | OUR | 2025-06-26 | View |
| 510(k) | K250669 | Adaptix Interbody System with Titan nanoLOCK Surface Technology | MAX | 2025-04-22 | View |
| 510(k) | K241992 | Catalyft LS Expandable Interbody System | OVD | 2024-10-28 | View |
| 510(k) | K243007 | CD Horizon Spinal System | NKB | 2024-10-23 | View |
| 510(k) | K233951 | CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw) | NKB | 2024-03-27 | View |
| 510(k) | K233830 | OsteoCool 2.0 RF Ablation System | GEI | 2024-02-28 | View |
| 510(k) | K232141 | CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System (Modular Extended Tab Head) | NKB | 2023-08-16 | View |
| 510(k) | K231090 | Zevo Anterior Cervical Plate System | KWQ | 2023-06-15 | View |
| 510(k) | K231184 | CD Horizon Spinal System | OLO | 2023-05-26 | View |
| 510(k) | K223764 | INFINITY OCT System | NKG | 2023-01-11 | View |
| 510(k) | K223153 | Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface Technology | MAX | 2022-12-16 | View |
| 510(k) | K221646 | CD HORIZON ASTUTE SPINAL SYSTEM; CD HORIZON Growth Rod Conversion Set; CD HORIZON SPINAL SYSTEM; CD Horizon Fenestrated Screw Set; COLORADO 2 SPINAL System; GDLH POSTERIOR SPINAL SYSTEM; SHILLA Growth Guidance System; TENOR SPINAL SYSTEM | NKB | 2022-10-04 | View |
| 510(k) | K222383 | Anteralign LS Spinal System with Titan nanoLOCK Surface Technology MAZORX Stealth(TM) Edition | OLO | 2022-09-29 | View |
| 510(k) | K221180 | Anteralign(TM) Spinal System with Titan NanoLOCK Surface Technology Navigated Instruments | OLO | 2022-05-25 | View |
| 510(k) | K214011 | 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 | OLO | 2022-02-09 | View |
| 510(k) | K212524 | Anteralign Spinal System with Titan nanoLOCK Surface Technology | MAX | 2021-12-08 | View |
| 510(k) | K212653 | Catalyft LS Expandable Interbody System | MAX | 2021-11-19 | View |
| 510(k) | K211958 | CD Horizon Spinal System | NKB | 2021-07-21 | View |
| 510(k) | K211441 | Navigated Anterolateral Disc Prep Instruments | OLO | 2021-06-09 | View |
| 510(k) | K211258 | Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA Interbody System, Endoskeleton TAS & TAS Hyp Interbody System, Endoskeleton TL Interbody System, Endoskeleton TL Hyp. Interbody System, Endoskeleton TO Interbody System, Endoskeleton TT Interbody System | MAX | 2021-05-26 | View |
| 510(k) | K210425 | Catalyft PL Expandable Interbody System | MAX | 2021-05-24 | View |
| 510(k) | K203678 | CD HORIZON Spinal System | NQP | 2021-01-15 | View |
| 510(k) | K203291 | CD Horizon Spinal System Instruments | OLO | 2020-12-08 | View |
| 510(k) | K201407 | CD Horizon Spinal System | NKB | 2020-09-10 | View |
| 510(k) | K202328 | CD Horizon Spinal System | NKB | 2020-09-08 | View |
| 510(k) | K191788 | CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium, DIVERGENCE-L Anterior/Oblique Lumbar Fusion System | MAX | 2020-03-23 | View |
| 510(k) | K192502 | Anatomic PEEK Cervical Fusion System, Anatomic PEEK PTC Cervical Fusion System, Capstone Spinal System, Capstone PTC Spinal System, Capstone Control Spinal System, Capstone Control PTC Spinal System, Clydesdale Spinal System, Clydesdale PTC Spinal System, Cornerstone PSR Cervical Fusion System, Crescent Spinal System, Crescent Spinal System Titanium, Divergence Anterior Cervical Fusion System (For Stand-Alone Interbody Device Only), Divergence-L Anterior/Oblique Lumbar Fus | MAX | 2020-01-22 | View |
| 510(k) | K193011 | CD Horizon Fenestrated Screw Set | NKB | 2020-01-10 | View |
| 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 |
| 510(k) | K173338 | Navigated INFINITY Instruments | OLO | 2018-01-18 | View |
| 510(k) | K172328 | SOVEREIGN Spinal System | OVD | 2017-11-02 | View |
| 510(k) | K171689 | ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with TiONIC Technology | MAX | 2017-10-05 | View |
| 510(k) | K171107 | CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal System | MAX | 2017-09-26 | View |
| 510(k) | K163375 | INFINITY OCT System | NKG | 2017-08-21 | View |
| 510(k) | K162212 | DIVERGENCE-L ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM | MAX | 2017-05-19 | View |
| 510(k) | K163181 | TRANSLACE Spinal Tethering System | OWI | 2017-05-16 | View |
| 510(k) | K163581 | Navigated ELEVATE Inserter, Navigated Disc Prep Instruments | OLO | 2017-04-14 | View |
| 510(k) | K163279 | Medtronic Transportation/Sterilization Cassettes | KCT | 2017-02-23 | View |
| 510(k) | K163301 | CD HORIZON® Spinal System | NKB | 2016-12-20 | View |
| PMA | P090029 | Prosthesis, intervertebral disc | MJO | 2016-12-15 | View |
| 510(k) | K162680 | SOVEREIGN® Spinal System | OVD | 2016-12-14 | View |
| 510(k) | K162379 | CD HORIZON® Spinal System | NKB | 2016-11-16 | View |
| 510(k) | K162494 | CD HORIZON® Spinal System | NKB | 2016-10-04 | View |
| PMA | P000058 | Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction | NEK | 2016-09-29 | View |
| PMA | P000054 | Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction | MPW | 2016-09-16 | View |
| 510(k) | K160528 | ANATOMIC PEEK PTC Cervical Fusion System | ODP | 2016-03-28 | View |
| 510(k) | K160418 | PERIMETER Interbody Fusion Device | MAX | 2016-03-07 | View |
| 510(k) | K153438 | PERIMETER C (Titanium) Spinal System | ODP | 2016-03-02 | View |
| 510(k) | K153442 | CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with the STEALTHSTATION System, Medtronic Reusable Instruments for Use with the IPC POWEREASE System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION and IPC POWEREASE Systems | NKB | 2016-02-18 | View |
| 510(k) | K153589 | CD HORIZON Spinal System | NKB | 2016-02-10 | View |
| 510(k) | K152241 | Medtronic Transportation/Sterilization Cassettes | KCT | 2016-01-20 | View |
No matching devices.