Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3002807561

FEI Number

3002807561

Entity Name

MEDTRONIC B.V. (EOC)

City/State/Country

HEERLEN Limburg, NL

Establishment Address

EARL BAKKENSTRAAT 10, HEERLEN Limburg 6422 PJ, NL

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Medtronic, Inc. (Owner Number: 2112641)

Owner / Operator Contact Address

710 Medtronic Parkway, Minneapolis, MN 55432, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K120605

PMA Number

N/A

All Registered Proprietary Names

CAPSTONE Spinal System SOVEREIGN Spinal System VERTEX® Reconstruction System CD HORIZON® Spinal System SCREWDRIVER Shiley CPAP SYSTEM AND BRONCHO-CATH W/CPAP SYSTEM BronchoCath with CPAP Parietex Hydrophilic 2-Dimensional Mesh SealGuard Evac Tracheal Tubes SealGuard Tracheal Tubes Tube, tracheal (w/wo connector) Adaptor Extender Kit Sprint Quattro Secure MRI SureScan Lead DF-1 Port Pin Plug Subcutaneous Lead Tunneling Tool Sprint Quattro Secure S MRI SureScan Lead Sprint Quattro Secure S Lead Sprint Quattro MRI SureScan Lead Sprint Quattro Lead Transvene Lead Transvene SVC Lead Adaptor Kit IS-1 Port Pin Plug Kit Sprint Quattro Secure Lead Tube tracheostomy and tube cuff Shiley CD Perc Trauma M3/M4 Monitor Parietene DS Composite Mesh Versatex SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INNER CANNULA Shiley Extended XLT Pearltene Macroporous Mesh Pearltene Macroporous Mesh, LPM1515, LPM1515X3, LPM1510, LPM1510X3 Symbotex ProGrip Tube, tracheal (w/wo connector) Safety Flex BronchoCath with CPAP Shiley TUBE, BRONCHIAL (W/WO CONNECTOR) VenaSeal Closure System Permacol Surgical Implant US

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2008-05-08
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2009-11-19
HXX	Screwdriver	Orthopedic	Class 1	888.4540	1992-12-12
BYE	Attachment, Breathing, Positive End Expiratory Pressure	Anesthesiology	Class 2	868.5965	2025-02-17
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2023-01-30
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2025-02-17
NVY	Permanent Defibrillator Electrodes	Unknown	Class 3	N/A	2008-03-12
LWS	Implantable Cardioverter Defibrillator (Non-Crt)	Unknown	Class 3	N/A	2008-03-12
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2025-02-17
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2008-01-31
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2008-01-31
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2008-01-31
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2008-01-31
NQP	Posterior Metal/Polymer Spinal System, Fusion	Orthopedic	Class 2	888.3070	2008-01-31
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2008-01-31
DRY	Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4330	2014-10-20
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2023-01-30
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2023-01-30
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2025-02-17
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2023-01-30
OXJ	Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects	General, Plastic Surgery	Class 2	878.3300	2023-01-30
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2023-01-30
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2023-01-30
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2025-02-17
BTS	Tube, Bronchial (W/Wo Connector)	Anesthesiology	Class 2	868.5720	2025-02-17
PJQ	Agent, Occluding, Vascular, Permanent	Unknown	Class 3	N/A	2017-12-14
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2023-01-30
OXK	Mesh, Surgical, Collagen, Large Abdominal Wall Defects	General, Plastic Surgery	Class 2	878.3300	2023-01-30

Official Correspondent

No official correspondent registered.

US Agent Details

Michelle Obenauer Business: Medtronic Sofamor Danek USA, Inc. (Pyramid Place) Email: michelle.obenauer@medtronic.com Phone: (901) 3992117

Related Public Records

Same Entity

Medtronic, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3007042319	HeartWare, Inc.	Miami Lakes, FL, US
3004497303	MEDTRONIC MEXICO EG	EMPALME Sonora, MX
3015192387	CATHWORKS	Newport Beach, CA, US
3004185781	Medtronic, Inc.	Tempe, AZ, US
3012520654	MEDTRONIC, INC.	Billerica, MA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K103464	Medtronic, Inc.	PACIFIC XTREME PTCA BALLOON DILATATION CATHETER	2010-12-22
K111339	Medtronic, Inc.	HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS)	2011-06-08
K223430	Life Spine, Inc.	ProLift Micro Expandable Spacer System	2023-05-04
K102293	Globus Medical, Inc.	CALIBER SPACER	2011-01-05
K193541	Nu Vasive, Incorporated	NuVasive Cohere Thoracolumbar Interbody System	2020-03-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2007	Guidant Corporation	3	Guidant Zoom Latitude Programming System, Model 3120, Programmer/Recorder/Monitor (PRM). A portable cardiac rhythm management system designed to be used with Guidant implantable pulse generators. Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA.
Z-0003-2018	St Jude Medical Inc.	3	Fortify VR - Model Numbers: CD1231-40 and CD1231-40Q; Fortify ST VR, Model Numbers: CD1241-40 and CD1241-40Q; Fortify Assura VR, Model Numbers: CD1257-40, CD1257-40Q, CD1357-40C, CD1357-40Q; Fortify Assura ST VR, Model Numbers: CD1263-40, CD1263-40Q, CD1363-40C, CD1363-40Q; Fortify DR, Model Numbers: CD2231-40 and CD2231-40Q; Fortify ST DR, Model Numbers: CD2241-40 and CD2241-40Q; Fortify Assura DR, Model Numbers: CD2257-40, CD2257-40Q, CD2357-40C, CD2357-40Q; Fortify Assura ST DR, Model Numbers: CD2263-40, CD2263-40Q, CD2363-40C, CD2363-40Q Product Usage Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing
Z-0037-2012	Boston Scientific CRM Corp	3	LATITUDE Paceart Integration Software, version 1.00 Model 6472. LATITUDE Paceart Integration is software and therefore does not have any serial numbers. However, the software version affected is version 1.00 and is distributed on USB pen drives. These pen drives are lot number controlled and denoted as Model 6493. When used in conjunction with the LATITUDE EMR Integration software transfers data files from the Boston Scientific LATITUDE Patient Management system to a clinic's Paceart system.
Z-0044-2017	Teleflex Medical	2	Willy Rusch GmbH Tracheostomy Tube Set Cannulation of tracheotomised patients, particularly in the case of a narrow tracheostoma and narrow-lumen tracheas. When using cannulas with curr. For short term intermittent inflation.
Z-0036-2013	Medtronic Sofamor Danek USA Inc	2	ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 176-503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002807561. Last updated year: 2026. Please use registration number 3002807561 when referencing this establishment in official correspondence.