Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

175 results for "Medtronic Sofamor Danek USA, Inc."
1–24 of 175
Search insights Median review: 84d Cleared: 100% Top manufacturer: Medtronic Sofamor Danek USA, Inc. Lead specialty: Orthopedic
Cleared Oct 29, 2026
Symmetrix™ PX Spinal System
K262572 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 94d
Cleared Jul 17, 2026
Catalyft PL Expandable Interbody System
K253011 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 301d
Cleared Jul 14, 2026
Symmetrix™ L Spinal System
K261020 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 109d
Cleared Jun 05, 2026
OsteoCool™ RF Ablation System
K253656 · GEI
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 197d
Cleared Apr 21, 2026
CD Horizon™ ModuLeX™ Fenestrated Screw Set
K260216 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 88d
Cleared Jan 21, 2026
Infinity™ OCT System
K254165 · NKG
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 30d
Cleared Jan 07, 2026
CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)
K253941 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 29d
Cleared Oct 24, 2025
CD Horizon™ Spinal System
K253335 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 24d
Cleared Oct 24, 2025
Infinity™ OCT System
K253129 · NKG
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 29d
Cleared Sep 04, 2025
Endoskeleton™ Interbody Systems
K251444 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 118d
Cleared Jun 26, 2025
The Rialto™ SI Fusion System
K251395 · OUR
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 52d
Cleared Apr 22, 2025
Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology
K250669 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 48d
Cleared Oct 28, 2024
Catalyft™ LS Expandable Interbody System
K241992 · OVD
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 112d
Cleared Oct 23, 2024
CD Horizon™ Spinal System
K243007 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 27d
Cleared Mar 27, 2024
CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)
K233951 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 103d
Cleared Feb 28, 2024
OsteoCool™ 2.0 RF Ablation System
K233830 · GEI
Medtronic Sofamor Danek USA, Inc.
General & Plastic Surgery · 89d
Cleared Aug 16, 2023
CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw)
K232141 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 29d
Cleared Jun 15, 2023
Zevo Anterior Cervical Plate System
K231090 · KWQ
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 59d
Cleared May 26, 2023
CD Horizon™ Spinal System
K231184 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 30d
Cleared Jan 11, 2023
INFINITY OCT System
K223764 · NKG
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 27d
Cleared Dec 16, 2022
Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface Technology
K223153 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 71d
Cleared Oct 04, 2022
CD HORIZON™ ASTUTE™ SPINAL SYSTEM
K221646 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 120d
Cleared Sep 29, 2022
Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX...
K222383 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 55d
Cleared May 25, 2022
Anteralign(TM) Spinal System with Titan NanoLOCK Surface Technology Navigated...
K221180 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 30d