Medtronic Sofamor Danek USA, Inc. is one of 26109 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: Symmetrix™ PX Spinal System, Catalyft PL Expandable Interbody System, Symmetrix™ L Spinal System
174
Total
163
Cleared
0
Denied
Medtronic Sofamor Danek USA, Inc. has 163 FDA 510(k) cleared orthopedic devices. Based in Memphis, US.
Latest FDA clearance: Oct 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.
174 devices
Cleared
Oct 29, 2026
Symmetrix™ PX Spinal System
Orthopedic
94d
Cleared
Jul 17, 2026
Catalyft PL Expandable Interbody System
Orthopedic
301d
Cleared
Jul 14, 2026
Symmetrix™ L Spinal System
Orthopedic
109d
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
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