Data / Medical devices / United States / Medtronic Sofamor Danek Usa, Inc.

Medtronic Sofamor Danek Usa, Inc.: FDA-registered device maker in Memphis, TN, United States, 219 510(k) clearances and 21 PMA approvals

Name: Medtronic Sofamor Danek Usa, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Medtronic Sofamor Danek Usa, Inc. is registered with the FDA (registration 3003120897) in Memphis, TN, United States. It lists 122 device types. The FDA files 219 510(k) clearances and 21 PMA approvals under its listings, the newest dated February 12, 2026. 3 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3003120897
Address: 4340 Swinnea Road, Memphis, TN, United States, 38118
Owner or operator: Medtronic, Inc. (2112641)
Roles: Manufacturer, Manufacturer for export, Remanufacturer, Repackager or relabeler, Specification developer
First device listed: February 15, 1978
Registered through: 2027
Brand names listed: , MOTORS, ACPii Atlantis Cervial Plate, AEX Generator Refurbished, ANTERIOR CERVICAL PLATE SYSTEM, ARTHROSCOPE, ARTiC-L 3D Ti Spinal System with TiONIC Technology, ATLANTIS Anterior Cervical Plate System, ATLANTIS ESSENTIALS" Anterior Cervical Plate System, ATLANTIS- Anterior Cervical Plate System and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Arthroscopic	NBH	1	Manufacturer	accessdata.fda.gov
Appliance, Fixation, Spinal Interlaminal	KWP	2	Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Appliance, Fixation, Spinal Intervertebral Body	KWQ	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Arthroscope	HRX	2	Manufacturer	accessdata.fda.gov
Awl	HWJ	1	Manufacturer, Remanufacturer, Repackager or relabeler	accessdata.fda.gov
Bender	HXW	1	Manufacturer	accessdata.fda.gov
Bit, Drill	HTW	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Bone Cement, Posterior Screw Augmentation	PML	2	Manufacturer	accessdata.fda.gov
Bone Fixation Cerclage, Sublaminar	OWI	2	Manufacturer	accessdata.fda.gov
Bone Grafting Material, Dental, With Biologic Component	NPZ	3	Manufacturer	accessdata.fda.gov
Broach	HTQ	1	Manufacturer	accessdata.fda.gov
Bur, Ear, Nose And Throat	EQJ	1	Manufacturer	accessdata.fda.gov
Caliper	KTZ	1	Manufacturer	accessdata.fda.gov
Cannula, Surgical, General & Plastic Surgery	GEA	1	Manufacturer	accessdata.fda.gov
Catheter, Continuous Flush	KRA	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Cement, Bone, Vertebroplasty	NDN	2	Manufacturer	accessdata.fda.gov
Chisel (Osteotome)	KDG	1	Manufacturer	accessdata.fda.gov
Chisel, Surgical, Manual	FZO	1	Manufacturer	accessdata.fda.gov
Clamp	HXD	1	Manufacturer	accessdata.fda.gov
Container, Specimen, Sterile	FMH	1	Manufacturer	accessdata.fda.gov
Corkscrew	HWI	1	Manufacturer	accessdata.fda.gov
Crimper, Pin	HXQ	1	Manufacturer	accessdata.fda.gov
Curette	HTF	1	Repackager or relabeler	accessdata.fda.gov
Cutter, Surgical	FZT	1	Manufacturer	accessdata.fda.gov
Cutter, Wire	HXZ	1	Manufacturer	accessdata.fda.gov
Deep Brain Stimulation For The Treatment Of Dystonia	SGS	3	Manufacturer	accessdata.fda.gov
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)	NIK	3	Manufacturer	accessdata.fda.gov
Dispenser, Cement	KIH	1	Manufacturer	accessdata.fda.gov
Dissector, Surgical, General & Plastic Surgery	GDI	1	Manufacturer	accessdata.fda.gov
Drills, Burrs, Trephines & Accessories (Simple, Powered)	HBE	2	Manufacturer	accessdata.fda.gov
Driver, Prosthesis	HWR	1	Manufacturer	accessdata.fda.gov
Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes	NVN	3	Manufacturer	accessdata.fda.gov
Electrode, Needle	GXZ	2	Manufacturer	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Manufacturer	accessdata.fda.gov
Elevator	HTE	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Extractor	HWB	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction	NEK	3	Manufacturer	accessdata.fda.gov
Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction	MPW	3	Manufacturer	accessdata.fda.gov
Forceps	HTD	1	Manufacturer	accessdata.fda.gov
Gauge, Depth	HTJ	1	Manufacturer	accessdata.fda.gov
Generator, Lesion, Radiofrequency	GXD	2	Manufacturer	accessdata.fda.gov
Growing Rod System	PGM	2	Manufacturer	accessdata.fda.gov
Guide, Surgical, Instrument	FZX	1	Manufacturer	accessdata.fda.gov
Hammer, Surgical	FZY	1	Manufacturer	accessdata.fda.gov
Holder, Needle; Orthopedic	HXK	1	Manufacturer	accessdata.fda.gov
Hook, Surgical, General & Plastic Surgery	GDG	1	Manufacturer	accessdata.fda.gov
Impactor	HWA	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Implantable Cardioverter Defibrillator (Non-Crt)	LWS	3	Manufacturer	accessdata.fda.gov
Implantable Pacemaker Pulse-Generator	DXY	3	Manufacturer	accessdata.fda.gov
Implantable Pulse Generator, Pacemaker (Non-Crt)	LWP	3	Manufacturer	accessdata.fda.gov
Implanted Electrical Device Intended For Treatment Of Fecal Incontinence	QON	3	Manufacturer	accessdata.fda.gov
Injector And Syringe, Angiographic	DXT	2	Repackager or relabeler	accessdata.fda.gov
Instrument, Bending Or Contouring	HXP	1	Manufacturer	accessdata.fda.gov
Instrument, Compression	HWN	1	Manufacturer	accessdata.fda.gov
Instrument, Cutting, Orthopedic	HTZ	1	Manufacturer	accessdata.fda.gov
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	HWE	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, Cervical	ODP	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, Lumbar	MAX	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, Cervical	OVE	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, Lumbar	OVD	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Knife, Orthopedic	HTS	1	Manufacturer	accessdata.fda.gov
Leadless Pacemaker	PNJ	3	Manufacturer	accessdata.fda.gov
Light, Surgical, Carrier	FSZ	2	Manufacturer	accessdata.fda.gov
Mallet	HXL	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Mixer, Cement, For Clinical Use	JDZ	1	Manufacturer	accessdata.fda.gov
Motor, Drill, Pneumatic	HBB	2	Manufacturer	accessdata.fda.gov
Motor, Surgical Instrument, Ac-Powered	GEY	1	Manufacturer	accessdata.fda.gov
Motor, Surgical Instrument, Pneumatic Powered	GET	1	Manufacturer	accessdata.fda.gov
Neurological Stereotaxic Instrument	HAW	2	Manufacturer	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Orthopedic Stereotaxic Instrument	OLO	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Orthosis, Spinal Pedicle Fixation	MNI	2	Manufacturer	accessdata.fda.gov
Orthosis, Spine, Plate, Laminoplasty, Metal	NQW	2	Manufacturer	accessdata.fda.gov
Orthosis, Spondylolisthesis Spinal Fixation	MNH	2	Manufacturer	accessdata.fda.gov
Osteotome	HWM	1	Manufacturer	accessdata.fda.gov
Pacemaker/Icd/Crt Non-Implanted Components	OSR	3	Manufacturer	accessdata.fda.gov
Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	OSH	2	Manufacturer	accessdata.fda.gov
Permanent Defibrillator Electrodes	NVY	3	Manufacturer	accessdata.fda.gov
Pliers, Surgical	HTC	1	Manufacturer	accessdata.fda.gov
Posterior Cervical Screw System	NKG	2	Manufacturer	accessdata.fda.gov
Posterior Metal/Polymer Spinal System, Fusion	NQP	2	Manufacturer	accessdata.fda.gov
Probe	HXB	1	Manufacturer	accessdata.fda.gov
Probe, Radiofrequency Lesion	GXI	2	Manufacturer	accessdata.fda.gov
Programmer, Pacemaker	KRG	3	Manufacturer	accessdata.fda.gov
Prosthesis, Intervertebral Disc	MJO	3	Manufacturer, Manufacturer for export	accessdata.fda.gov
Prosthesis, Spinous Process Spacer/Plate	NQO	3	Manufacturer	accessdata.fda.gov
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)	NKE	3	Manufacturer	accessdata.fda.gov
Pulse Generator, Permanent, Implantable	NVZ	3	Manufacturer	accessdata.fda.gov
Pump, Infusion, Implanted, Programmable	LKK	3	Manufacturer	accessdata.fda.gov
Rasp	HTR	1	Repackager or relabeler	accessdata.fda.gov
Reamer	HTO	1	Manufacturer	accessdata.fda.gov
Retractor	GAD	1	Manufacturer	accessdata.fda.gov
Rongeur	HTX	1	Repackager or relabeler	accessdata.fda.gov
Sacroiliac Joint Fixation	OUR	2	Manufacturer	accessdata.fda.gov
Scissors, Orthopedic, Surgical	HRR	1	Manufacturer	accessdata.fda.gov
Screwdriver	HXX	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Spinal Vertebral Body Replacement Device	MQP	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Spinal Vertebral Body Replacement Device - Cervical	PLR	2	Manufacturer	accessdata.fda.gov
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	KCT	2	Manufacturer	accessdata.fda.gov
Stimulator, Electrical, Evoked Response	GWF	2	Manufacturer	accessdata.fda.gov
Stimulator, Electrical, Implantable, For Incontinence	EZW	3	Manufacturer	accessdata.fda.gov
Stimulator, Electrical, Implanted, For Essential Tremor	PJS	3	Manufacturer	accessdata.fda.gov
Stimulator, Electrical, Implanted, For Parkinsonian Symptoms	NHL	3	Manufacturer	accessdata.fda.gov
Stimulator, Electrical, Implanted, For Parkinsonian Tremor	MHY	3	Manufacturer	accessdata.fda.gov
Stimulator, Nerve	ETN	2	Manufacturer	accessdata.fda.gov
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief	LGW	3	Manufacturer	accessdata.fda.gov
Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy	QRB	3	Manufacturer	accessdata.fda.gov
Stimulator, Thalamic, Epilepsy, Implanted	MBX	3	Manufacturer	accessdata.fda.gov
Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence	QPT	3	Manufacturer	accessdata.fda.gov
Syringe, Piston	FMF	2	Repackager or relabeler	accessdata.fda.gov
System, Facet Screw Spinal Device	MRW	U	Manufacturer	accessdata.fda.gov
Tamp	HXG	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Tap, Bone	HWX	1	Manufacturer	accessdata.fda.gov
Tape, Measuring, Rulers And Calipers	FTY	1	Manufacturer	accessdata.fda.gov
Tape, Orthopedic	HXT	1	Manufacturer	accessdata.fda.gov
Template	HWT	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Thoracolumbosacral Pedicle Screw System	NKB	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Tray, Surgical	LRP	1	Manufacturer	accessdata.fda.gov
Tray, Surgical, Instrument	FSM	1	Manufacturer	accessdata.fda.gov
Trephine	HWK	1	Manufacturer	accessdata.fda.gov
Wire, Surgical	LRN	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Wrench	HXC	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 219.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
February 12, 2026	K253381	Stealth AXiS Surgical System with Stealth AXiS Spine clinical application	OLO	Substantially Equivalent	Medtronic Navigation, Inc.	accessdata.fda.gov
January 21, 2026	K254165	Infinity OCT System	NKG	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.	accessdata.fda.gov
October 24, 2025	K253129	Infinity OCT System	NKG	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.	accessdata.fda.gov
October 28, 2024	K241992	Catalyft LS Expandable Interbody System	OVD	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.	accessdata.fda.gov
October 23, 2024	K243007	CD Horizon Spinal System	NKB	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.	accessdata.fda.gov
February 28, 2024	K233830	OsteoCool 2.0 RF Ablation System	GEI	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.	accessdata.fda.gov
August 16, 2023	K232141	CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System (Modular Extended Tab Head)	NKB	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.	accessdata.fda.gov
July 18, 2023	K230716	Robotic Graft Delivery Instruments	OLO	Substantially Equivalent	Medtronic Sofamor Danek, Inc.	accessdata.fda.gov
May 26, 2023	K231184	CD Horizon Spinal System	OLO	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.	accessdata.fda.gov
January 23, 2023	K223494	CD Horizon Spinal System	NKB	Substantially Equivalent	Medtronic	accessdata.fda.gov
September 29, 2022	K222383	Anteralign LS Spinal System with Titan nanoLOCK Surface Technology MAZORX Stealth(TM) Edition	OLO	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.	accessdata.fda.gov
May 25, 2022	K221244	CD Horizon Spinal System	NKB	Substantially Equivalent	Medtronic	accessdata.fda.gov
May 25, 2022	K221180	Anteralign(TM) Spinal System with Titan NanoLOCK Surface Technology Navigated Instruments	OLO	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.	accessdata.fda.gov
April 18, 2022	K220131	KYPHON VuE Bone Cement	NDN	Substantially Equivalent	Tecres S.P.A.	accessdata.fda.gov
April 12, 2022	K214010	Anteralign Spinal System with Titan nanoLOCK Surface Technology	MAX	Substantially Equivalent	Medtronic Sofamor Danek USA	accessdata.fda.gov
February 9, 2022	K214011	Catalyft PL Expandable Interbody System Navigated Instruments, Anteralign TL Spinal System with Titan nanoLOCK Surface Technology Navigated Instruments, and CD Horizon Solera Voyager Spinal System Navigated, Guided, and Powered Drivers	OLO	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.	accessdata.fda.gov
December 13, 2021	K212428	Centerpiece Plate Fixation System	NQW	Substantially Equivalent	Medtronic Sofamor Danek	accessdata.fda.gov
December 8, 2021	K212524	Anteralign Spinal System with Titan nanoLOCK Surface Technology	MAX	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.	accessdata.fda.gov
November 19, 2021	K212653	Catalyft LS Expandable Interbody System	MAX	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.	accessdata.fda.gov
July 21, 2021	K211958	CD Horizon Spinal System	NKB	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.	accessdata.fda.gov
June 23, 2021	K211596	CD Horizon Spinal System	OLO	Substantially Equivalent	Medtronic	accessdata.fda.gov
May 24, 2021	K210425	Catalyft PL Expandable Interbody System	MAX	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.	accessdata.fda.gov
April 30, 2021	K210637	CD Horizon Spinal System	NKB	Substantially Equivalent	Medtronic	accessdata.fda.gov
January 15, 2021	K203678	CD HORIZON Spinal System	NQP	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.	accessdata.fda.gov
September 10, 2020	K201407	CD Horizon Spinal System	NKB	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.	accessdata.fda.gov
September 8, 2020	K202328	CD Horizon Spinal System	NKB	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.	accessdata.fda.gov
August 19, 2020	K201362	CD Horizon Fenestrated Screw Set, CD Horizon Spinal System, Kyphon HV-R Bone Cement	PML	Substantially Equivalent	Medtronic	accessdata.fda.gov
January 10, 2020	K193011	CD Horizon Fenestrated Screw Set	NKB	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.	accessdata.fda.gov
January 8, 2020	K191581	Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion Device	OVD	Substantially Equivalent	Titan Spine, Inc.	accessdata.fda.gov
November 22, 2019	K192336	Navigated Anterolateral Disc Prep Instruments	OLO	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.	accessdata.fda.gov
October 15, 2019	K190840	Medtronic Transportation / Sterilization Cassettes	KCT	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.	accessdata.fda.gov
October 3, 2019	K191066	CD Horizon Astute Spinal System	NQP	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.	accessdata.fda.gov
September 12, 2019	K191148	Medtronic HV-R Bone Cement, Kyphon Xpede Bone Cement, CD Horizon Fenestrated Screw Set	PML	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.	accessdata.fda.gov
August 29, 2019	K192054	Endoskeleton TAS Plate	OVD	Substantially Equivalent	Titan Spine, Inc.	accessdata.fda.gov
August 26, 2019	K191039	Navigated T2 STRATOSPHERE Inserters and Navigated Templates	OLO	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.	accessdata.fda.gov
August 16, 2019	K192018	Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic Interbody Fusion Device, Endoskeleton TO Interbody Fusion Device, Endoskeleton TT Interbody Fusion Device, Endoskeleton TC Interbody Fusion Device, Endoskeleton TCS Interbody Fusion Device, Endoskeleton TL Interbody Fusion Device	ODP	Substantially Equivalent	Titan Spine, Inc.	accessdata.fda.gov
August 6, 2019	K191565	Endoskeleton TCS Interbody Fusion Device	OVE	Substantially Equivalent	Titan Spine, Inc.	accessdata.fda.gov
May 6, 2019	K190165	Capstone Control Spinal System	MAX	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.	accessdata.fda.gov
February 11, 2019	K183557	Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TO Interbody Fusion Device, Endoskeleton® TT Interbody Fusion Device, Endoskeleton® TC Interbody Fusion Device, Endoskeleton® TCS Interbody Fusion Device, Endoskeleton® TL Interbody Fusion Device, Endoskeleton® TA Vertebral Body Replacement (VBR) Device	ODP	Substantially Equivalent	Titan Spine, Inc.	accessdata.fda.gov
January 16, 2019	K183510	T2 STRATOSPHERE Expandable Corpectomy System	MQP	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.	accessdata.fda.gov
January 2, 2019	K181864	Polaris RF Ablation System	GXD	Substantially Equivalent	Baylis Medical Company, Inc.	accessdata.fda.gov
November 2, 2018	K182121	CD HORIZON Spinal System Instruments for use with MAZOR X Stealth Edition	OLO	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.	accessdata.fda.gov
October 4, 2018	K182436	POWEREASE System	HBE	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.	accessdata.fda.gov
September 19, 2018	K181328	T2 STRATOSPHERE Expandable Corpectomy System	MQP	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.	accessdata.fda.gov
August 29, 2018	K182119	CD HORIZON Spinal System	NKB	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.	accessdata.fda.gov
February 13, 2018	K173535	Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody Fusion Device and Endoskeleton® TCS Interbody Fusion Device	ODP	Substantially Equivalent	Titan Spine, LLC	accessdata.fda.gov
January 18, 2018	K173338	Navigated INFINITY Instruments	OLO	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.	accessdata.fda.gov
December 20, 2017	K173125	T2 STRATOSPHERE Expandable Corpectomy System	MQP	Substantially Equivalent	Medtronic Sofamor Danek	accessdata.fda.gov
November 2, 2017	K172328	SOVEREIGN Spinal System	OVD	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.	accessdata.fda.gov
October 5, 2017	K171689	ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with TiONIC Technology	MAX	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.	accessdata.fda.gov
September 26, 2017	K171107	CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal System	MAX	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.	accessdata.fda.gov
September 7, 2017	K170381	Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex Mini	GEI	Substantially Equivalent	Medtronic Advanced Energy	accessdata.fda.gov
August 21, 2017	K163375	INFINITY OCT System	NKG	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.	accessdata.fda.gov
July 6, 2017	K171031	CRESCENT Spinal System	MAX	Substantially Equivalent	Medtronic Sofamor Danek	accessdata.fda.gov
June 13, 2017	K171468	FUSE Spinal System	MAX	Substantially Equivalent	Medtronic Sofamor Danek	accessdata.fda.gov
May 16, 2017	K163181	TRANSLACE Spinal Tethering System	OWI	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.	accessdata.fda.gov
May 11, 2017	K170679	CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION® and IPC® POWEREASE® Systems	NKB	Substantially Equivalent	Medtronic Sofamor Danek	accessdata.fda.gov
April 14, 2017	K163581	Navigated ELEVATE Inserter, Navigated Disc Prep Instruments	OLO	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.	accessdata.fda.gov
March 20, 2017	K170296	CoreCath 2.7S	GEI	Substantially Equivalent	Medtronic Advanced Energy	accessdata.fda.gov
December 20, 2016	K163301	CD HORIZON® Spinal System	NKB	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.	accessdata.fda.gov
December 14, 2016	K162680	SOVEREIGN® Spinal System	OVD	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.	accessdata.fda.gov
November 16, 2016	K162379	CD HORIZON® Spinal System	NKB	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.	accessdata.fda.gov
October 4, 2016	K162494	CD HORIZON® Spinal System	NKB	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.	accessdata.fda.gov
August 12, 2016	K161210	RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC(TM) Powerease(TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation(TM) and IPC(TM) Powerease(TM) Systems	OUR	Substantially Equivalent	Medtronic Sofamor Danek	accessdata.fda.gov
March 7, 2016	K160418	PERIMETER Interbody Fusion Device	MAX	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.	accessdata.fda.gov
February 18, 2016	K153442	CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with the STEALTHSTATION System, Medtronic Reusable Instruments for Use with the IPC POWEREASE System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION and IPC POWEREASE Systems	NKB	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.	accessdata.fda.gov
February 10, 2016	K153589	CD HORIZON Spinal System	NKB	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.	accessdata.fda.gov
January 20, 2016	K152241	Medtronic Transportation/Sterilization Cassettes	KCT	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.	accessdata.fda.gov
January 6, 2016	K152604	KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set	PML	Substantially Equivalent	Medtronic Sofamor Danek USA, Incorporated	accessdata.fda.gov
December 30, 2015	K153463	CD HORIZON Spinal System, IPC POWEREASE System	NKB	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.	accessdata.fda.gov
November 24, 2015	K152057	OsteoCool V-3 RF Ablation System	GEI	Substantially Equivalent	Baylis Medical Company, Inc.	accessdata.fda.gov
November 16, 2015	K151227	KYPHON XPEDE Bone Cement	NDN	Substantially Equivalent	Medtronic	accessdata.fda.gov
November 13, 2015	K152277	PIVOX(tm) Oblique Lateral Spinal System	MAX	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.	accessdata.fda.gov
November 12, 2015	K152623	ATLANTIS Anterior Cervical Plate System	KWQ	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.	accessdata.fda.gov
November 5, 2015	K152248	CD HORIZON Spinal System	NKB	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.	accessdata.fda.gov
October 27, 2015	K152457	CD HORIZON Spinal System	NKB	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.	accessdata.fda.gov
June 16, 2015	K150231	Navigated Disc Prep Instruments and CAPSTONE Trials	OLO	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.	accessdata.fda.gov
June 11, 2015	K150135	DIVERGENCE-L Anterior/Oblique Lumbar Fusion System	MAX	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.	accessdata.fda.gov
June 9, 2015	K142559	ELEVATE Spinal System	MAX	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.	accessdata.fda.gov
May 21, 2015	K150297	PlasmaBlade UPPP and Suction Coagulator	GEI	Substantially Equivalent	Medtronic Advanced Energy	accessdata.fda.gov
April 8, 2015	K143019	CD HORIZON Spinal System, IPC POWEREASE System	NKB	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.	accessdata.fda.gov
February 25, 2015	K150200	CD HORIZON Growth Rod Conversion Set	PGM	Substantially Equivalent	Medtronic Sofamor Danek USA, Incorporated	accessdata.fda.gov
February 13, 2015	K143375	CD HORIZON Spinal System, Medtronic Navigated Reusable Instruments	NKB	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.	accessdata.fda.gov
February 12, 2015	K143628	Navigated Vertex Select Instruments	OLO	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.	accessdata.fda.gov
February 12, 2015	K143569	CD HORIZON Spinal System	NKB	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.	accessdata.fda.gov
January 28, 2015	K142940	Endoskeleton TCS System	OVE	Substantially Equivalent	Titan Spine, LLC	accessdata.fda.gov
January 21, 2015	K141599	DIVERGENCE ANTERIOR CERVICAL FUSION SYSTEM	OVE	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.	accessdata.fda.gov
December 31, 2014	K143175	AEx Generator; PlasmaBlade T	GEI	Substantially Equivalent	Medtronic Advanced Energy	accessdata.fda.gov
December 4, 2014	K141632	ZEVO (TM) ANTERIOR CERVICAL PLATE SYSTEM	KWQ	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.	accessdata.fda.gov
December 1, 2014	K143141	CD HORIZON Spinal System	NKB	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.	accessdata.fda.gov
December 1, 2014	K142591	CD HORIZON Spinal System	NKB	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.	accessdata.fda.gov
October 21, 2014	K141604	CD HORIZON SPINAL SYSTEM	NKB	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.	accessdata.fda.gov
October 1, 2014	K142450	DIVERGENCE Anterior Cervical Fusion System	ODP	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.	accessdata.fda.gov
July 17, 2014	K140750	SHILLA GROWTH GUIDANCE SYSTEM	PGM	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.	accessdata.fda.gov
July 14, 2014	K141605	CD HORIZON SPINAL SYSTEM	NKB	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.	accessdata.fda.gov
July 9, 2014	K140417	DIVERGENCE MINI-PLATE ANTERIOR CERVICAL FUSION SYSTEM	KWQ	Substantially Equivalent	Medtronic Sofamor Danek, Inc.	accessdata.fda.gov
July 2, 2014	K140055	ENDOSKELETON(R) TL INTERBODY FUSION DEVICE	MAX	Substantially Equivalent	Titan Spine, LLC	accessdata.fda.gov
May 22, 2014	K140454	NAVIGATED CD HORIZON SOLERA SCREWDRIVER/TAPS	OLO	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.	accessdata.fda.gov
April 28, 2014	K133653	ANATOMIC PEEK PTC CERVICAL FUSION SYSTEM	ODP	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.	accessdata.fda.gov
March 13, 2014	K133205	CAPSTONE PTC SPINAL SYSTEM, CLYDESDALE PTC SPINAL SYSTEM	MAX	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
September 18, 2025	P240011	Medtronic Altaviva System	QPT	15	September 14, 2026	accessdata.fda.gov
October 20, 2023	P220012	Aurora EV-ICD System	LWS	75	July 31, 2026	accessdata.fda.gov
April 6, 2016	P150033	MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEM	PNJ	225	September 8, 2026	accessdata.fda.gov
July 24, 2014	P090029	PRESTIGE LP CERVICAL DISC	MJO	20	August 9, 2024	accessdata.fda.gov
March 14, 2011	P080025	MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEM	QON	349	October 9, 2026	accessdata.fda.gov
February 8, 2011	P090013	REVO MRI SURESCAN IPG AND PACING SYSTEM	LWP	325	June 5, 2025	accessdata.fda.gov
May 12, 2009	P060023	BRYAN CERVICAL DISC PROSTHESIS	MJO	7	March 18, 2020	accessdata.fda.gov
March 9, 2007	P050053	INFUSE BONE GRAFT	NPZ	63	August 26, 2026	accessdata.fda.gov
November 21, 2005	P040001	X STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM	NQO	19	December 12, 2014	accessdata.fda.gov
April 30, 2004	P000054	INFUSE BONE GRAFT	MPW	72	August 26, 2026	accessdata.fda.gov
July 2, 2002	P000058	INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE	NEK	90	August 26, 2026	accessdata.fda.gov
June 26, 2002	P010031	CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATION	NIK	902	October 5, 2026	accessdata.fda.gov
January 29, 1999	P980035	MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWARE	NVZ	822	October 23, 2026	accessdata.fda.gov
October 9, 1998	P980016	VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS	LWS	933	October 5, 2026	accessdata.fda.gov
September 29, 1997	P970004	MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL	EZW	448	October 9, 2026	accessdata.fda.gov
July 31, 1997	P960009	MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM	MHY	528	October 6, 2026	accessdata.fda.gov
December 9, 1993	P920015	MEDTRONIC(R) TRANSVENE LEAD SYSTEM	NVY	294	August 19, 2026	accessdata.fda.gov
August 24, 1989	P890003	SYNERGYST II PULSE GENERATOR MODELS 7070 & 7071	NVZ	459	July 31, 2026	accessdata.fda.gov
March 14, 1988	P860004	MEDTRONIC(R) SYNCHROMED(TM) PUMP & INFUSION SYSTEM	LKK	442	October 16, 2026	accessdata.fda.gov
November 30, 1984	P840001	ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYS	LGW	612	October 6, 2026	accessdata.fda.gov
November 16, 1982	P820003	VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR	LWP	138	March 20, 2025	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
July 12, 2023	92749	Class II	Ongoing	CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K	Incorrect Laser Marking - Solera Awl Tip Tap	accessdata.fda.gov
April 27, 2021	87842	Class II	Terminated	Braive Growth Modulation System Break-Off Set Screws - Product Usage: intended to limit further progression of the spinal curvature and provide correction of the thoracic curve while allowing continued skeletal growth by	Product is impacted by a thread profile defect due to a manufacturing issue.	accessdata.fda.gov
March 17, 2021	87626	Class II	Terminated	Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Small, 8 mm, Product Number 5146-1208-N - Product Usage: indicated to be used with supplemental fixation cleared by the FDA for use in th	The shelf box identifies a small device actually contains a large device, and the shelf box identifying a large device actually contains a small device.	accessdata.fda.gov

Compare with other makers

Updated September 14, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.