Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015531529

FEI Number

3015531529

Entity Name

Medtronic Neurosurgery

City/State/Country

Fort Worth, TX, US

Establishment Address

4620 North Beach Street, Fort Worth, TX 76137, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

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

K152700

PMA Number

N/A

All Registered Proprietary Names

CSF-FLOW CONTROL VALVE PS MEDICAL CRANIAL HAND DRILL P-S MED. LUMBO PERITONEAL & VENTRIC PS MEDICAL CSF-FLOW CONTROL VALVE BECKER EXTERNAL DRAINAGE AND MONITORING SYSTEM PS MEDICAL CSF-ACCESS DEVICE Timesh System INTRACRANIAL PRESSURING MONITORING SYSTEM MACROPORE PROTECTIVE SHEET MEDTRONIC PS MEDICAL STRATA TYPE VA Becker External Drainage and Monitoring System P-S MEDICAL VENTRICULAR ACCESS PORT Duet External Drainage and Monitoring System (EDMS) TIMESH CRANIAL FIXATION SYSTEM TIMESH TITANIUM MINI-SOFTPLATE/SCRE MEDTRONIC PS MEDICAL POLYURETHANE SHUNT IPI ALGO-LINE CATHETER PS MEDICAL CATHETER PLACEMENT KIT RIVULET VENTRICULAR AND SNAP SHUNT SUBDURAL EVACUATING PORT SYSTEM Medtronic External Drainage and Monitoring System (EDMS) Duet EDMS STRATA NSC BURR HOLE VALVE STRATA NSC BURR HOLE SHUNT ASSEMBLY MEDTRONIC PS MEDICAL CHANNELSCOPE ENDOSCOPE BECKER EXTERNAL DRAINAGE/MONITOR SYSTEM LUMBAR CATHETER ARES Antibiotic Impregnated Catheters StrataMR II Valves and Shunts TIMESH TITANIUM MINI-SOFTPLATE & MICRO-SOFT PLATE/SCREW SYSTEM MEDTRONIC PS MEDICAL MURPHYSCOPE PS MEDICAL STRATA II VALVE MEDTRONIC M2 MAGNET ADJUST. TOOL PS MEDICAL DISPOSABLE SUBCUTANEOUS CATHETER PASSER PS MEDICAL DISPOSABLE SUB MEDTRONIC PS MEDICAL EXTERNAL DRAINAGE AND MONITORING VENTRICULAR CATHETER P-S MEDICAL CSF ACCESS DEV 15MM/25M Strata NSC Lumboperitoneal Shunt System Strata NSC LP Valve Strata NSC LP Shunt Strata NSC Lumboperitoneal Valve SERIES 5000 ENDOSCOPE CON ENDOSCOPE CONSOLE TIMESH SYSTEM PS MEDICAL CSF SIPHON CONTROL DEVIC SUBDURAL EVACUATING PORT SYSTEM CRANIAL ACCESS KIT SEPS-CA SEPS-CAL SEPS-CAND Strata NSC LP Shunt System PS MEDICAL DELTA BURR HOLE VALVE MEDTRONIC PS MEDICAL INVISX CRANIAL FIXATION SYSTEM CSF-VENTRICULAR CATHETER, STANDARD Exacta External Drainage and Monitoring System (EDMS) PS MEDICAL BUTTON VALVE PS MEDICAL VENTRICULOSTOMY KIT PS MEDICAL CSF-ON/OFF FLUSHING RESE MEDTRONIC PS MEDICAL STRATA NSC VALVE AND SHUNT ASSEMBLIES CSF CARDIAC PERITONEAL CATHETER MEDTRONIC PS MEDICAL EXACTA DRAINAGE SYSTEM POLE CLAMP MEDTRONIC PS MEDICAL EXACTA DRAINAGE SYSTEM CSF-VENTRICULOSTOMY RESERVOIR PS MEDICAL DELTA CSF-FLOW CONTROL VALVE BIPOLAR PENCIL P-S CSF-VENTRICULAR CATHETER, FLANG CSF-CARDIAC/PERITONEAL CATHETER StrataMR Valves and Shunts

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2008-09-15
HBG	Drills, Burrs, Trephines & Accessories (Manual)	Neurology	Class 2	882.4300	1992-12-22
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2008-09-15
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2008-09-15
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2008-09-15
GWM	Device, Monitoring, Intracranial Pressure	Neurology	Class 2	882.1620	2008-09-15
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2006-07-06
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2007-12-10
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2007-12-10
GWM	Device, Monitoring, Intracranial Pressure	Neurology	Class 2	882.1620	1992-12-22
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2006-07-06
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2006-07-06
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	1992-11-22
GWM	Device, Monitoring, Intracranial Pressure	Neurology	Class 2	882.1620	2020-07-14
LKG	Port & Catheter, Implanted, Subcutaneous, Intraventricular	Neurology	Class 2	882.5550	2006-07-06
PCB	External Cerebrospinal Fluid (Csf) Diversion	Neurology	Class 2	882.5560	2024-11-04
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2002-07-05
JEY	Plate, Bone	Dental	Class 2	872.4760	2006-07-06
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2008-09-15
MAJ	Catheter, Percutaneous, Intraspinal, Short Term	Anesthesiology	Class 2	868.5120	1992-12-22
GWG	Endoscope, Neurological	Neurology	Class 2	882.1480	1998-11-17
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2008-09-15
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2008-09-15
GWM	Device, Monitoring, Intracranial Pressure	Neurology	Class 2	882.1620	2020-07-14
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2025-03-11
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2008-09-15
GWG	Endoscope, Neurological	Neurology	Class 2	882.1480	1998-11-17
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2008-09-15
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2012-01-01
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2022-05-04
JEY	Plate, Bone	Dental	Class 2	872.4760	2008-09-15
GWG	Endoscope, Neurological	Neurology	Class 2	882.1480	1998-11-17
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2008-09-15
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2008-09-15
GYK	Instrument, Shunt System Implantation	Neurology	Class 1	882.4545	1992-12-22
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2008-09-15
LKG	Port & Catheter, Implanted, Subcutaneous, Intraventricular	Neurology	Class 2	882.5550	2006-07-06
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2014-02-17
GCT	Light Source, Endoscope, Xenon Arc	Gastroenterology, Urology	Class 2	876.1500	2006-07-06
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2006-07-06
EZX	Mesh, Surgical, Metal	General, Plastic Surgery	Class 2	878.3300	2006-07-06
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2006-07-06
GXR	Cover, Burr Hole	Neurology	Class 2	882.5250	2006-07-06
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2006-07-06
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2008-09-15
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2008-09-15
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2009-12-14
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2008-09-15
GXN	Plate, Cranioplasty, Preformed, Non-Alterable	Neurology	Class 2	882.5330	2006-07-06
GXR	Cover, Burr Hole	Neurology	Class 2	882.5250	2006-07-06
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2008-09-15
GWM	Device, Monitoring, Intracranial Pressure	Neurology	Class 2	882.1620	2020-07-14
HCA	Catheter, Ventricular	Neurology	Class 2	882.4100	2020-07-14
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2008-09-15
HBG	Drills, Burrs, Trephines & Accessories (Manual)	Neurology	Class 2	882.4300	1992-12-22
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2008-09-15
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2008-09-15
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2008-09-15
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	1992-12-22
GWM	Device, Monitoring, Intracranial Pressure	Neurology	Class 2	882.1620	1992-12-22
LKG	Port & Catheter, Implanted, Subcutaneous, Intraventricular	Neurology	Class 2	882.5550	2006-07-06
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2008-09-15
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2006-07-06
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2008-09-15
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2008-09-15
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2016-04-14

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

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
K062348	Medtronic Neurosurgery	TIMESH SELF DRILLING SCREW	2006-09-08
K981246	Integra Neurocare, LLC	BEVERLY REFERENTIAL VALVE (NL850-9710) WITH INTEGRAL PERITONEAL CATHETER (NL850-9720) VALVE KIT (NL850-9730)	1999-05-26
K020558	Integra Neurosciences	LICOX CC1.G2 BRAIN OXYGEN CATHETER-MICROPROBE	2002-03-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0034-2022	Flower Orthopedics Corporation	2	Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
Z-0014-2014	Synthes USA HQ, Inc.	2	Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016	Ortho Solutions Inc 330 Franklin Tnpk	2	Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015531529. Last updated year: 2026. Please use registration number 3015531529 when referencing this establishment in official correspondence.