Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2648988

FEI Number

3000204775

Entity Name

INTEGRA NEUROSCIENCES

City/State/Country

ANASCO, PR, US

Establishment Address

ROAD 402 NORTH, KM 1.2, ANASCO, PR 00610, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Integra LifeSciences Corporation (Owner Number: 9004007)

Owner / Operator Contact Address

1100 Campus Rd, Princeton, NJ 08540, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K190180

PMA Number

N/A

All Registered Proprietary Names

Disposable Shunt Passer Horizontal-Vertical Lumbar Valve System Spetzler Lumbar Peritoneal Shunt Systems Hermetic Lumbar Catheters Hermetic Plus External CSF Drainage MoniTorr ICP External CSF Drainage CUSA EXCEL Ultrasonic Surgical Aspirator System TRAUMA CATHETER, VENTRICULAR CATHETER SET Jarit Integra Ruggles-Redmond Miltex Padgett MicroFrance Wound Measuring Kit MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage System VENTRICULAR DRAINAGE SYSTEM Hermetic Jarit Ruggles-Redmond Padgett Miltex Integra MicroFrance Galea Elevator Arkis Galea Elevator MoniTorr CSF External Drainage Syst CUSA Clarity Ultrasonic Surgical Aspirator System; C7023; C7123; C7623; C7601; C7601EA OraMem Absorbable Collagen Membrane BioMend Absorbable Collagen Membrane HeliMend Absorbable Collagen Membrane Pudenz Flushing Valve NeuraWrap Nerve Protector CUSA® Clarity 23 kHz Expanded CEM Nosecone Integra Maurice Worldwide Shunt System Essential Shunt Kits CUSA® Clarity 23 kHz Standard Laparoscopic Tip CUSA® Clarity 23 kHz Extended Laparoscopic Tip Suturable DuraGen Dural Regenration Matrix Accudrain External CSF Drainage Sys LPV II Standard and Mini Valves External CSF Drainage Systems Fischer Fischer Cannula CODMAN Elsberg Ventricular Cannula MoniTorr ICP External CSF Drainage External Drainage Set CUSA Clarity Ultrasonic Surgical Aspirator System; C7602; C7602EA CUSA Excel+ Ultrasonic Surgical Aspirator System; C2623; C5623; CUSAEXCEL2; C2600; C5601; C5602 Helistat Absorbable Collagen Hemostatic Sponge Helitene Absorbable Collagen Hemostatic Agent OraFOAM Absorbable Collagen Hemostatic Sponge Novus Valve System Alleghany CSF External Drainage Sys Pudenz Catheters Integra Reservoirs Braden Reservoir Pudenz Peritoneal Catheter Mishler Valve Systems Hermetic External CSF Drainage Syst Pudenz Valves On-Off Flushing Valves Multi-Purpose Valves External CSF Drainage Systems Pudenz Cardiac Catheters Codman External Drainage System II Spetzler Lumbar-Peritoneal System Sundt Shunt External Corotid Shunts OraMem Sustained Absorbable Collagen Membrane Biomend Extend Absorbable Collagen Membrane HeliMend Advanced Absorbable Collagen Membrane CUSA Clarity 23 kHz Single-Sided Bone Tip Edwards Barbaro Syringo Shunt Syste DuraGen Dural Graft Matrix Pudenz In-line Valve Systems LimiTorr Volume Limiting Drainage Biopatch CUSA Clarity 23kHz CEM Nosecone

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GYK	Instrument, Shunt System Implantation	Neurology	Class 1	882.4545	2007-12-12
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2016-09-27
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2007-12-12
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2007-12-12
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2007-12-12
LBK	Neurosurgical Ultrasonic Instruments	Unknown	Class U	N/A	2005-10-03
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2005-10-03
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2013-10-24
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	1981-04-24
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2023-03-15
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2013-10-24
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2019-02-01
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	1981-04-24
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2007-12-12
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2019-01-03
LBK	Neurosurgical Ultrasonic Instruments	Unknown	Class U	N/A	2019-01-03
LYC	Bone Grafting Material, Synthetic	Dental	Class 2	872.3930	2007-11-30
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2008-06-13
JXI	Cuff, Nerve	Neurology	Class 2	882.5275	2007-11-30
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2023-07-12
LBK	Neurosurgical Ultrasonic Instruments	Unknown	Class U	N/A	2023-07-12
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2016-06-07
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2007-12-12
LBK	Neurosurgical Ultrasonic Instruments	Unknown	Class U	N/A	2022-08-18
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2022-08-18
GXQ	Dura Substitute	Neurology	Class 2	882.5910	2007-11-30
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2007-12-12
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2007-12-12
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2007-12-12
HCD	Cannula, Ventricular	Neurology	Class 1	882.4060	2007-12-12
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2007-12-12
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2007-12-18
LBK	Neurosurgical Ultrasonic Instruments	Unknown	Class U	N/A	2016-10-21
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2016-10-21
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2015-02-20
LMF	Agent, Absorbable Hemostatic, Collagen Based	General, Plastic Surgery	Class 3	878.4490	2007-11-30
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2007-12-12
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2007-12-12
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2011-10-07
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2007-12-12
LYC	Bone Grafting Material, Synthetic	Dental	Class 2	872.3930	2007-11-30
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2022-10-06
LBK	Neurosurgical Ultrasonic Instruments	Unknown	Class U	N/A	2022-10-06
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2007-12-12
GXQ	Dura Substitute	Neurology	Class 2	882.5910	2007-11-30
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2007-12-12
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2007-12-12
SEL	Securement Wound Dressing For Reduction Of Infection	Unknown	Class U	N/A	2006-06-26
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2019-04-26
LBK	Neurosurgical Ultrasonic Instruments	Unknown	Class U	N/A	2019-04-26

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Integra LifeSciences Corporation

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3015194982	SURGICAL INNOVATION ASSOCIATES, INC.	Chicago, IL, US
3013505638	REBOUND THERAPEUTICS, CORPORATION	Irvine, CA, US
3006697299	INTEGRA LIFESCIENCES (IRELAND) LIMITED	SRAGH TULLAMORE Offaly, IE
9680837	INTEGRA MICROFRANCE SAS	SAINT AUBIN LE MONIAL Auvergne-Rhone-Alpes, FR
3004608878	INTEGRA LIFESCIENCES CORPORATION	CINCINNATI, OH, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K071458	Integra LifeSciences Corporation	MAYFIELD RADIOLUCENT DISPOSABLE SKULL PINS	2007-06-13
K981246	Integra Neurocare, LLC	BEVERLY REFERENTIAL VALVE (NL850-9710) WITH INTEGRAL PERITONEAL CATHETER (NL850-9720) VALVE KIT (NL850-9730)	1999-05-26
K922626	Andronic Devices, Ltd.	ADEPT INSTRUMENT POSITIONING ACCESSORY	1992-10-19
K820290	The Anspach Effort, Inc.	SELF RETAINING RETRACTOR FOR HAND SURG	1982-03-05
K760422	Cutter Laboratories, Inc.	SURGICAL RETRACTOR	1976-08-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0332-2022	Covidien Llc	U	Covidien Sonicision Battery Charger-intended to charge the Sonicision Reusable Battery Pack and to provide information on the battery charging progress and battery pack status Item Code: CBCA
Z-0031-2014	Aesculap, Inc.	1	UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
Z-0003-2022	Medtronic Perfusion Systems	2	Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.
Z-0021-2018	OriGen Biomedical, Inc.	2	The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire reinforcement layer on the tip of the device. A thin sheath is used to cover and secure the wire layer and is heat shrunk into a permanent position.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2648988. Last updated year: 2026. Please use registration number 2648988 when referencing this establishment in official correspondence.