Medtronic Sofamor Danek USA, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
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
Medtronic Sofamor Danek USA, Inc. has 160 FDA 510(k) cleared orthopedic devices. Based in Memphis, US.
Latest FDA clearance: Jun 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.
Regulatory submissions have been managed by Medtronic Sofamor Danek and Medtronic. 1 submission has an FDA-authorized Predetermined Change Control Plan (PCCP), indicating AI or software-based device development.
FDA 510(k) Regulatory Record - Medtronic Sofamor Danek USA, Inc.
171 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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