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Medtronic Sofamor Danek USA, Inc.

FDA 510(k) & PMA Approved Devices — 79 products

Total Devices79
Categories19
Latest FDA decision2026-07-28
TypeNumberDevice NameCodeDateActions
PMA P000058 Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinductionNEK2026-07-28 View
PMA P000054 Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinductionMPW2026-07-28 View
510(k) K253011 Catalyft PL Expandable Interbody SystemMAX2026-07-17 View
510(k) K261020 Symmetrix™ L Spinal SystemMAX2026-07-14 View
510(k) K253656 OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation SystemGEI2026-06-05 View
510(k) K260216 CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemNKB2026-04-21 View
510(k) K254165 Infinity™ OCT SystemNKG2026-01-21 View
510(k) K253941 CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)NKB2026-01-07 View
510(k) K253129 Infinity™ OCT SystemNKG2025-10-24 View
510(k) K253335 CD Horizon™ Spinal SystemNKB2025-10-24 View
510(k) K251444 Endoskeleton™ Interbody SystemsMAX2025-09-04 View
510(k) K251395 The Rialto™ SI Fusion SystemOUR2025-06-26 View
510(k) K250669 Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMAX2025-04-22 View
510(k) K241992 Catalyft™ LS Expandable Interbody SystemOVD2024-10-28 View
510(k) K243007 CD Horizon™ Spinal SystemNKB2024-10-23 View
PMA P090029 Prosthesis, intervertebral discMJO2024-08-09 View
510(k) K233951 CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)NKB2024-03-27 View
510(k) K233830 OsteoCool™ 2.0 RF Ablation SystemGEI2024-02-28 View
510(k) K232141 CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System (Modular Extended Tab Head)NKB2023-08-16 View
510(k) K231090 Zevo Anterior Cervical Plate SystemKWQ2023-06-15 View

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