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INTEGRA NEUROSCIENCES

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
26489883000204775INTEGRA NEUROSCIENCES1N2026-01-01ROAD 402 NORTH, KM 1.2 ANASCO PR US 00610

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
129691773461133P850010HELISTAT(TM) ABSORBABLE COLLAGEN HEMOSTATIC SPONGELMF1985-11-08
129691815776200P840062COLLACOTE(TM)LPG1985-11-08
129691115660182P810006COLLASTATLMF1981-12-10
129691804661727K992216BIOMEND EXTEND ABSORBABLE COLLAGEN MEMBRANE, BIOMEND ABSORBABLE COLLAGEN MENBRANELYC1999-07-26
129691421461965K983603REFLECTIVE SPHERE STANDARD PROBE AND REFLECTIVE SPHERE DYNAMIC REFERENCE FRAMEHAW1998-11-10
129691604503948K982180DURAGEN DURAL GRAFT MATRIXGXQ1999-07-06
129691408053185K981262CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEMLFL1998-07-06
129691964117342K974708GEMINI STANDARD AND MINI VALVESJXG1998-03-10
129691238886251K973525MAURICE WORLDWIDE SHUNT SYSTEMJXG1997-12-16
129691027266655K972994EXTERNAL CSF DRAINAGE MANAGEMENT SYSTEMSJXG1997-11-03
129691608911441K971617ENDOSCOPIC VENTRICULAR CATHETERJXG1997-07-31
129691894235753K970983PERITONEAL/CARDIAC CATHETERJXG1997-06-13
129691297804740K970658LUMBAR DRAINAGE ACCESSORY KITJXG1997-05-19
129691389925282K964371SHUNT TAP WITH ICP MONITORING ACCESS PORTJXG1997-01-31
129691964666166K963802SHUNT TAPJXG1996-12-12
129691745465512K961859NOVUS STANDARD AND PEDIATRIC VALVESJXG1996-12-16
129691406943699K932769CAMINO VENTRICULAR DRAINAGE SYSTEMJXG1995-03-30
129691068977830K924408COLLA-TEC ABSORBABLE COLLAGEN MEMBRANELYC1995-08-22
129691584229564K920156CLINICAL NEURO SYST MONITORR EXT CSF DRAIN/MONI SYJXG1992-03-16
129691710884806K895868HEYER-SCHULTE DISPOSABLE PERITONEAL CATHETER PASSEGYK1989-10-31
129691814887643K894072THE PUDENZ IN LINE VALVEJXG1989-08-07
129691095963773K891456HEYER-SCHULTE (CSF) VENTRI ACCESS(RESERV/ANTECHAMJXG1989-06-23
129691389852607K873771HEYER-SCHULTE(R) ONE PIECE SHUNT VENT. CATH. INTROGYK1987-12-18
129691996034365K864676HEYER-SCHULTE HERMETIC EXTERNAL CSF DRAIN. SYSTEMJXG1986-12-29
129691904772670K854049HEYER-SCHULTE SYRINGO PERITONEAL SHUNTJXG1985-11-27
129692057061035K823790VENTRICULAR ACCESS SYSTEMLKG1983-04-28
129691160878605K820247EXTERNAL VENTRICULAR DRAINAGE SYS.JXG1982-02-18
129691014635216K811288SPETZLER LUMBAR-PERITONEAL SYSTEMJXG1981-06-26
129691926125002K802586AMERICAN HEYER-SCHULTE LOW PROFILE VALVEJXG1980-12-18
129692024408817K760785MISHLER 2 CHAMB FLUSHING VALVE,ANTI-SYPHJXG1976-11-01
129691398626056K760784MISHLER 2 CHAMB FLUSHING VALVE,STANDJXG1976-11-01
129691954289082K760502VALVE, ANTI-SYPHON MODEL PUDENZE FLUSH.JXG1976-08-30
129692020915121K760501VALVE, STANDARD MODEL PUDENZE FLUSHINGJXG1976-08-30
129691824474489K230427CUSA Clarity Ultrasonic Surgical Aspirator SystemLFL2023-07-11
129691746230866K221835CUSA Clarity Ultrasonic Surgical Aspirator SystemLFL2022-08-22
129691942806843K221763CUSA Clarity Ultrasonic Surgical Aspirator SystemLFL2022-07-15
129691850096439K191684MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage SystemJXG2019-10-11
129691670523884K190180CUSA Clarity Ultrasonic Surgical Aspirator SystemLFL2019-04-01
129691755722249K182809CUSA Clarity Ultrasonic Surgical Aspirator SystemLFL2018-12-07
129691345798448K161992Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt SystemsJXG2016-09-22
129692016034898K161882CUSA Clarity Ultrasonic Surgical Aspirator SystemLFL2016-10-14
129691201944691K153041Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional LabelingJXG2016-03-14
129691892720264K141674CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRATOR SYSTEMLFL2014-11-06
129692052951077K113570INTEGRA CUSA NXT INFERIOR FOWARD BONE TIPLFL2012-02-22
129691575045850K111741INTEGRA(TM) CUSA NXT(TM) BONE TIPSLFL2011-08-23
129691776535364K102258CUSA NXT EXTENDED LENGTH TIPLFL2011-06-10
129691156881718K092388DURAGEN PLUS DURAL REGENERATION MATRIX- SPINAL MATRIX, MODEL DP2013SM, INTEGRA SPINAL MEND DURAL REGENERATION MATRIX, MOGXQ2010-01-21
129691948464912K091302INTEGRA MOZAIK AND OS MOLDABLE MORSELSMQV2009-12-04
129691737532453K090864CUSA SHEAR TIP, AN ACCESSORY OF THE CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEMLFL2009-05-08
129691795204646K081459CUSA SELECTOR NXT ULTRASONIC TISSUE ABLATION SYSTEMLFL2008-08-13
129691988002658K072929LIMITORR VOLUME LIMITING EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM, MODELS INS9020, INS9030JXG2007-12-07
129691058030068K072207DURAGEN XS DURAL REGENERATION MATRIXGXQ2007-08-23
129691886777497K071669INTEGRA SELECTOR ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONE TIPLFL2007-08-17
129691087135514K062599MONITORR ICP EXTERNAL DRAINAGE AND MONITORING SYSTEMSJXG2006-09-27
129692026484921K051947RADIONICS CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONELFL2005-08-22
129691922260101K043427DURAGEN II DURAL REGENERATION MATRIXGXQ2005-01-12
129691808555202K042825ACCUDRAIN EXTERNAL CSF DRAINAGE SYSTEMJXG2004-12-21
129692020203644K041620NEURA WRAP NERVE PROTECTORJXI2004-07-16
129691188378649K032817EXTERNAL DRAINAGE SETJXG2003-10-06
129691353387804K032693DURAGEN PLUS DURAL GRAFT MATRIXGXQ2003-09-30
129691384582507K030289HERMETIC PLUS EXTERNAL CSF DRAINAGE SYSTEMS, INS-8301,INS-8302,INS-8700, NL850-830NJXG2003-02-26
129691391792932K022554MONITORR ICP EXTERNAL CSF DRAINAGE AND MONITORING SYSTEMJXG2002-08-23
129691277946391K021989SELECTOR INTEGRA ULTRASONIC SURGICAL ASPIRATOR, MODEL OM 1530000M3LFL2002-09-13
129691159662740K011168NEUROGEN NERVE GUIDEJXI2001-06-22
129691419770286K003229BIOPATCH ANTIMICROBIAL DRESSINGSEL2001-10-26
129691773769341
129691029764925
129691159013706
129691333595682
129691385218818
129691786446524

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JXG312019-10-11
LFL162023-07-11
GXQ52010-01-21
JXI22004-07-16
LYC21999-07-26
GYK21989-10-31
LMF21985-11-08
MQV12009-12-04
SEL12001-10-26
HAW11998-11-10
LPG11985-11-08
LKG11983-04-28

PMN#