Medtronic Sofamor Danek USA, Inc. - FDA 510(k) Cleared Devices
Recent clearances: OsteoCool™ RF Ablation System, CD Horizon™ ModuLeX™ Fenestrated Screw Set, Infinity™ OCT System
171
Total
160
Cleared
0
Denied
FDA 510(k) Regulatory Record - Medtronic Sofamor Danek USA, Inc. Orthopedic ✕
156 devices
Cleared
Jun 05, 2026
OsteoCool™ RF Ablation System
Orthopedic
197d
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
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