Medtronic Sofamor Danek USA, Inc. - FDA 510(k) Cleared Devices
170
Total
159
Cleared
0
Denied
Medtronic Sofamor Danek USA, Inc. has 159 FDA 510(k) cleared orthopedic devices. Based in Memphis, US.
Latest FDA clearance: Apr 2026. Active since 2000.
Browse the complete list of FDA 510(k) cleared orthopedic devices from this manufacturer. Filter by specialty or product code using the sidebar.
1 submission has an FDA-authorized Predetermined Change Control Plan (PCCP), indicating AI or software-based device development.
170 devices
Cleared
Apr 21, 2026
CD Horizon™ ModuLeX™ Fenestrated Screw Set
Orthopedic
88d
Cleared
Jan 21, 2026
Infinity™ OCT System
Orthopedic
30d
Cleared
Jan 07, 2026
CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)
Orthopedic
29d
Cleared
Oct 24, 2025
Infinity™ OCT System
Orthopedic
29d
Cleared
Oct 24, 2025
CD Horizon™ Spinal System
Orthopedic
24d
Cleared
Sep 04, 2025
Endoskeleton™ Interbody Systems
Orthopedic
118d
Cleared
Jun 26, 2025
The Rialto™ SI Fusion System
Orthopedic
52d
Cleared
Apr 22, 2025
Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology
Orthopedic
48d
Cleared
Oct 28, 2024
Catalyft™ LS Expandable Interbody System
Orthopedic
112d
Cleared
Oct 23, 2024
CD Horizon™ Spinal System
Orthopedic
27d
Cleared
Mar 27, 2024
CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)
Orthopedic
103d
Cleared
Feb 28, 2024
OsteoCool™ 2.0 RF Ablation System
General & Plastic Surgery
89d
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