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
FDA 510(k) Regulatory Record - Medtronic Sofamor Danek USA, Inc. Orthopedic ✕
159 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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