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Medtronic Sofamor Danek USA, Inc. FDA Approvals
0 new drug approvals and 31 device clearances on file. Matched by name to MDT.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| Catalyft PL Expandable Interbody System510(k)Jul 17, 2026Orthopedic |
| Symmetrix L Spinal System510(k)Jul 14, 2026Orthopedic |
| OsteoCool RF Ablation System; OsteoCool 2.0 RF Ablation System510(k)Jun 5, 2026General, Plastic Surgery |
| CD Horizon ModuLeX Fenestrated Screw Set; CD Horizon ModuLeX Spinal System510(k)Apr 21, 2026Orthopedic |
| Infinity OCT System510(k)Jan 21, 2026Orthopedic |
| CD Horizon ModuLeX Spinal System (LigaMAS Head Assembly)510(k)Jan 7, 2026Orthopedic |
| Infinity OCT System510(k)Oct 24, 2025Orthopedic |
| CD Horizon Spinal System510(k)Oct 24, 2025Orthopedic |
| Endoskeleton Interbody Systems510(k)Sep 4, 2025Orthopedic |
| The Rialto SI Fusion System510(k)Jun 26, 2025Orthopedic |
| Adaptix Interbody System with Titan nanoLOCK Surface Technology510(k)Apr 22, 2025Orthopedic |
| Catalyft LS Expandable Interbody System510(k)Oct 28, 2024Orthopedic |
| CD Horizon Spinal System510(k)Oct 23, 2024Orthopedic |
| CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)510(k)Mar 27, 2024Orthopedic |
| OsteoCool 2.0 RF Ablation System510(k)Feb 28, 2024General, Plastic Surgery |
| CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System (Modular Extended Tab Head)510(k)Aug 16, 2023Orthopedic |
| Zevo Anterior Cervical Plate System510(k)Jun 15, 2023Orthopedic |
| CD Horizon Spinal System510(k)May 26, 2023Neurology |
| INFINITY OCT System510(k)Jan 11, 2023Orthopedic |
| Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface Technology510(k)Dec 16, 2022Orthopedic |
| 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 SYSTEM510(k)Oct 4, 2022Orthopedic |
| Anteralign LS Spinal System with Titan nanoLOCK Surface Technology MAZORX Stealth(TM) Edition510(k)Sep 29, 2022Neurology |
| Anteralign(TM) Spinal System with Titan NanoLOCK Surface Technology Navigated Instruments510(k)May 25, 2022Neurology |
| 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 Drivers510(k)Feb 9, 2022Neurology |
| Anteralign Spinal System with Titan nanoLOCK Surface Technology510(k)Dec 8, 2021Orthopedic |
| Catalyft LS Expandable Interbody System510(k)Nov 19, 2021Orthopedic |
| CD Horizon Spinal System510(k)Jul 21, 2021Orthopedic |
| Navigated Anterolateral Disc Prep Instruments510(k)Jun 9, 2021Neurology |
| 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 System510(k)May 26, 2021Orthopedic |
| Catalyft PL Expandable Interbody System510(k)May 24, 2021Orthopedic |
| CD HORIZON Spinal System510(k)Jan 15, 2021Orthopedic |