Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Medtronic Sofamor Danek USA, Inc. · Predicate Candidate Screening
173 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
84 daysmedian FDA review time
174 days90th percentile
173clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253011 | Catalyft PL Expandable Interbody System | Medtronic Sofamor Danek USA, Inc. | 2026-07-17 | 301 | 0 |
| K261020 | Symmetrix™ L Spinal System | Medtronic Sofamor Danek USA, Inc. | 2026-07-14 | 109 | 0 |
| K253656 | OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation Sy | Medtronic Sofamor Danek USA, Inc. | 2026-06-05 | 197 | 0 |
| K260216 | CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ Modu | Medtronic Sofamor Danek USA, Inc. | 2026-04-21 | 88 | 0 |
| K254165 | Infinity™ OCT System | Medtronic Sofamor Danek USA, Inc. | 2026-01-21 | 30 | 0 |
| K253941 | CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly) | Medtronic Sofamor Danek USA, Inc. | 2026-01-07 | 29 | 0 |
| K253129 | Infinity™ OCT System | Medtronic Sofamor Danek USA, Inc. | 2025-10-24 | 29 | 0 |
| K253335 | CD Horizon™ Spinal System | Medtronic Sofamor Danek USA, Inc. | 2025-10-24 | 24 | 0 |
| K251444 | Endoskeleton™ Interbody Systems | Medtronic Sofamor Danek USA, Inc. | 2025-09-04 | 118 | 0 |
| K251395 | The Rialto™ SI Fusion System | Medtronic Sofamor Danek USA, Inc. | 2025-06-26 | 52 | 0 |
| K250669 | Adaptix™ Interbody System with Titan nanoLOCK™ Surface Techn | Medtronic Sofamor Danek USA, Inc. | 2025-04-22 | 48 | 0 |
| K241992 | Catalyft™ LS Expandable Interbody System | Medtronic Sofamor Danek USA, Inc. | 2024-10-28 | 112 | 0 |
| K243007 | CD Horizon™ Spinal System | Medtronic Sofamor Danek USA, Inc. | 2024-10-23 | 27 | 0 |
| K233951 | CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, a | Medtronic Sofamor Danek USA, Inc. | 2024-03-27 | 103 | 0 |
| K233830 | OsteoCool™ 2.0 RF Ablation System | Medtronic Sofamor Danek USA, Inc. | 2024-02-28 | 89 | 0 |
| K232141 | CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Hor | Medtronic Sofamor Danek USA, Inc. | 2023-08-16 | 29 | 0 |
| K231090 | Zevo Anterior Cervical Plate System | Medtronic Sofamor Danek USA, Inc. | 2023-06-15 | 59 | 0 |
| K231184 | CD Horizon™ Spinal System | Medtronic Sofamor Danek USA, Inc. | 2023-05-26 | 30 | 0 |
| K223764 | INFINITY OCT System | Medtronic Sofamor Danek USA, Inc. | 2023-01-11 | 27 | 0 |
| K223153 | Catalyft LS Expandable Interbody System with Titan nanoLOCK | Medtronic Sofamor Danek USA, Inc. | 2022-12-16 | 71 | 0 |
| K221646 | CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Co | Medtronic Sofamor Danek USA, Inc. | 2022-10-04 | 120 | 0 |
| K222383 | Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Te | Medtronic Sofamor Danek USA, Inc. | 2022-09-29 | 55 | 0 |
| K221180 | Anteralign(TM) Spinal System with Titan NanoLOCK Surface Tec | Medtronic Sofamor Danek USA, Inc. | 2022-05-25 | 30 | 0 |
| K214011 | Catalyft™ PL Expandable Interbody System Navigated Instrumen | Medtronic Sofamor Danek USA, Inc. | 2022-02-09 | 49 | 0 |
| K212524 | Anteralign Spinal System with Titan nanoLOCK Surface Technol | Medtronic Sofamor Danek USA, Inc. | 2021-12-08 | 119 | 0 |
| K212653 | Catalyft LS Expandable Interbody System | Medtronic Sofamor Danek USA, Inc. | 2021-11-19 | 88 | 7 |
| K211958 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2021-07-21 | 27 | 0 |
| K211441 | Navigated Anterolateral Disc Prep Instruments | Medtronic Sofamor Danek USA, Inc. | 2021-06-09 | 30 | 0 |
| K211258 | Endoskeleton TC Interbody System, Endoskeleton TCS Interbody | Medtronic Sofamor Danek USA, Inc. | 2021-05-26 | 30 | 0 |
| K210425 | Catalyft PL Expandable Interbody System | Medtronic Sofamor Danek USA, Inc. | 2021-05-24 | 102 | 1 |
| K203678 | CD HORIZON™ Spinal System | Medtronic Sofamor Danek USA, Inc. | 2021-01-15 | 29 | 0 |
| K203291 | CD Horizon Spinal System Instruments | Medtronic Sofamor Danek USA, Inc. | 2020-12-08 | 29 | 0 |
| K201407 | CD Horizon™ Spinal System | Medtronic Sofamor Danek USA, Inc. | 2020-09-10 | 105 | 0 |
| K202328 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2020-09-08 | 22 | 0 |
| K191788 | CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCE | Medtronic Sofamor Danek USA, Inc. | 2020-03-23 | 264 | 0 |
| K192502 | Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Ce | Medtronic Sofamor Danek USA, Inc. | 2020-01-22 | 132 | 0 |
| K193011 | CD Horizon™ Fenestrated Screw Set | Medtronic Sofamor Danek USA, Inc. | 2020-01-10 | 73 | 0 |
| K192336 | Navigated Anterolateral Disc Prep Instruments | Medtronic Sofamor Danek USA, Inc. | 2019-11-22 | 86 | 0 |
| K190840 | Medtronic Transportation / Sterilization Cassettes | Medtronic Sofamor Danek USA, Inc. | 2019-10-15 | 197 | 0 |
| K191066 | CD Horizon™ Astute™ Spinal System | Medtronic Sofamor Danek USA, Inc. | 2019-10-03 | 164 | 0 |
| K191148 | Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD | Medtronic Sofamor Danek USA, Inc. | 2019-09-12 | 135 | 0 |
| K191039 | Navigated T2 STRATOSPHERE Inserters and Navigated Templates | Medtronic Sofamor Danek USA, Inc. | 2019-08-26 | 129 | 0 |
| K190959 | ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL | Medtronic Sofamor Danek USA, Inc. | 2019-07-03 | 82 | 0 |
| K190165 | Capstone Control™ Spinal System | Medtronic Sofamor Danek USA, Inc. | 2019-05-06 | 95 | 0 |
| K183197 | PYRAMESH™ Implant System | Medtronic Sofamor Danek USA, Inc. | 2019-04-04 | 136 | 0 |
| K182885 | Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cerv | Medtronic Sofamor Danek USA, Inc. | 2019-02-06 | 114 | 0 |
| K183510 | T2 STRATOSPHERE Expandable Corpectomy System | Medtronic Sofamor Danek USA, Inc. | 2019-01-16 | 29 | 0 |
| K182497 | OsteoCool RF Ablation System | Medtronic Sofamor Danek USA, Inc. | 2019-01-15 | 125 | 0 |
| K182928 | CD Horizon™ Spinal System | Medtronic Sofamor Danek USA, Inc. | 2019-01-11 | 81 | 0 |
| K182121 | CD HORIZON Spinal System Instruments for use with MAZOR X St | Medtronic Sofamor Danek USA, Inc. | 2018-11-02 | 88 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda