FDA.reportPublic FDA data

Oonagh Lahiff

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96175443003112432Oonagh Lahiff1N2020-04-252 Pearl Court Allendale NJ US 07401

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
37651138565074P950019RAY THREADED FUSION CAGE (TFC)(TM) WITH INSTRUMENTATIONMAX1996-10-29
37651563662308K994347CENTAUR SPINAL SYSTEMKWQ2000-03-15
37651296400107K993402OPUS SPINAL SYSTEMMNI1999-12-20
37651056596225K993181HOWMEDICA OSTEONICS ACCP SYSTEM CORTICAL SCREWSKWQ1999-10-22
37651792762601K992792XIA SPINAL SYSTEM C-C ADAPTORKWQ1999-11-16
37651661567023K992784NEXT GENERATION RODDING SYSTEMKWQ1999-10-27
37652055270707K992344OSTEONICS ACCP SYSTEM LINE EXTENSIONKWQ1999-07-30
37651254871818K991055OSTEONICS SPINAL SYSTEM- ROD/ PLATE SYSTEMMNH1999-08-27
37651018676568K990922OSTEONICS SPINAL SYSTEM VERSATILE CROSS CONNECTORKWP1999-06-02
37651421638409K990059OSTEONICS SPINAL SYSTEM-EXPANDED INDICATIONSMNI1999-01-28
37651613252361K984375OSTEONICS SPINAL SYSTEM - SACRAL OFFSET CONNECTOR ASSEMBLYKWP1999-04-30
37651633210343K984302OSTEONICS SPINAL SYSTEM CYLINDRICAL BONE SCREWSMNH1998-12-18
37651781847622K984251XIA SPINE SYSTEMKWQ1999-02-24
37651492839095K983152OSTEONICS SPINAL SYSTEM 5.5MM & 10.0MM BONE SCREWSMNH1998-09-25
37651384171796K982494BWM SPINE SYSTEMKWP1998-09-08
37651614302046K981452OSTEONICS LONG ARM CONTAINMENT RINGKWP1998-05-20
37651921220494K964544OSTEONICS SPINAL SYSTEM - VARIABLE OFFSET CONNECTOR ASSEMBLYMNH1997-02-11
37651048033721K951725OSTEONICS SPINAL SYSTEMMNH1995-09-08
37651121240506K930009STRYKER 2S SPINAL SYSTEMKWP1994-09-01
37651449412688K183381Navigation Enabled InstrumentsOLO2019-05-17
37651369384524K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar CageMAX2019-07-25
37651497706055K172724XIA® 4.5 Spinal System, Power Adaptor Instrument AccessoryNKB2017-10-10
37651468223202K172104Ozark(tm) Cervical Plate SystemKWQ2017-08-23
37651165214150K172034Stryker Spine Navigation System with SpineMap 3D software application, OrthoLock, nGenius Spine Clamp, Navigated Drill Guide Set, Navigated Xia 3 Awl Tap, Navigated Xia 3 Serrato TapOLO2017-10-18
37651851827422K170496Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryNKB2017-05-16
37651614758854K161407Ascential IBD PEEKc SpacerODP2016-07-15
37651467777225K160978LITe BIO Delivery SystemFMF2016-07-08
37651811039906K160813EasyStepJDR2016-07-26
37651952746820K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryNKB2015-12-02
37651381133350K152532AERO -C Cervical Cage SystemODP2015-12-18
37651747364252K151755OASYS(r) SystemNKG2015-07-09
37651178258259K151726AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK Spacer, AVS Navigator PEEK Spacer, AVS ARIA PEEK SpacerMAX2016-01-20
37651336523214K150753OASYS SystemKWP2015-06-09
37651674036583K150539OASYS SystemNKG2015-05-12
37651160385141K150449LITe Plate SystemKWQ2015-03-20
37651065796249K143597Navigated XIA 4.5 Polyaxial ScrewdriverOLO2015-09-04
37651975740892K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer, AVS® Navigator PEEK Spacer, AVS® ARIA PEEK Spacer, AccuLIF TL and PL Cage, AVS® Anchor-L Spacer, Aero-AL Lumbar Cage SystemOVD2015-01-26
37651529437701K142741OASYS SystemKWP2015-01-15
37652015949222K142699LITe Plate SystemKWQ2014-12-31
37651462194875K142381Xia 3 Spinal SystemNKB2014-10-21
37651289356737K142251AVS AS PEEK SpacerODP2014-11-19
37652067016172K142237Aviator Anterior Cervical Plate (ACP) SystemKWQ2015-01-26
37651641690872K142114Xia® Growth Rod Conversion SetPGM2014-10-27
37651731814327K142066AERO-LL LUMBAR CAGE SYSTEMOVD2014-11-13
37651476266145K141941SPINEMASK TRACKER, SPINEMAP 3D 3.0-SOFTWARE,SPINEMAP 3D 3.0-UPGREADE, SPINEMAP 3D 3.0-ENABLE, SPINEMAP 3D 3.0-SALES DOLO2014-10-31
37651826009969K140400ES2 NEUROMONITORING ACCESSORY INSTRUMENTSETN2014-07-01
37651144142061K133328AERO-AL LUMBAR CAGE SYSTEMOVD2014-05-30
37651991898517K133188MANTIS & MANTIS REDUX SPINAL SYSTEM, RADIUS SPINAL SYSTEM, TRIO & TRIO+ SPINAL FIXATION SYSTEMS, AND TRIO TRAUMA SPINALNKB2013-12-17
37651719096421K122845ES2 SPINAL SYSTEM MODEL 48280XXXXNKB2012-12-07
37651194132967K122637LITE DECOMPRESSION SYSTEM- LIGHT CABLE MODEL 48089999FST2012-11-01
37651684943942K122113MEMORY METAL STAPLES, EASYCLIPJDR2013-03-12
37651195025387K121342XIA 4.5 SPINAL SYSTEMNKB2012-06-22
37651524843792K120486AVS AS PEEK SPACERODP2012-08-20
37651852662716K113802ESCALATE LAMINOPLASTY SYSTEMNQW2012-04-16
37651854656642K113666XIA 3 SPINAL SYSTEMNKB2012-08-28
37651386899161K112197MEMOMETAL INTRA-MEDULLARY BONE FASTENERHTY2011-11-17
37651644924353K111719OASYS SPINAL SYSTEMKWP2012-01-19
37651973652901K111478STRYKER SPINE POWER ADAPTOR (ACCESSORY INSTRUMENT)NKB2011-08-04
37651672409644K110419AVS ARIA NEUROMONITORING PROBE AND AVS ARIA PROBE DILATORSGXZ2011-07-28
37651833007227K103292TRIO TRAUMA SPINAL SYSTEMNKB2011-03-04
37651599924485K102606AVS ANCHOR-C CERVICAL CAGE SYSTEMOVE2011-04-22
37651850534290K102235MANTIS SPINAL SYSTEM & MANTIS REDUX SPINAL SYSTEMNKB2010-08-24
37651594018939K101183MODIFICATION TO: OASYS SYSTEMKWP2010-11-09
37651989036085K101144MODIFICATION TO:RADIUS SPINAL SYSTEMNKB2010-07-08
37651265679879K101051AVS A-LAT PEEK SPACERS, MODELS 48750XXX, 48751XXX, 48752XXX, 48753XXXMAX2010-08-12
37651684113538K100865AVA NAVIGATOR PEEK SPACERS, MODEL 48392XXX, 48393XXXMAX2010-08-11
37651963862141K100737MODIFICATION TO: TRIO+SPINAL FIXATION SYSTEMNKB2010-04-12
37651459280268K093864AVS ALIGN PEEK SPACERS MODEL 48328XXX, 48326XXXMAX2010-03-11
37651554820514K093704AVS PL PEEK SPACERSMAX2009-12-23
37651487918467K093670MODIFICATION TO: OASYS SYSTEMMNH2010-03-18
37651936458463K092631MANTIS REDUX SPINAL SYSTEMNKB2009-09-25
37651237171701K092605XIA 4.5 SPINAL SYSTEMNKB2009-12-03
37652055795315K091946VLIFT-S VERTEBRAL BODY REPLACEMENT SYSTEM, MODELS 488812XX, 488814XX, 488816XX, 488818XXMQP2009-09-25
37651718592728K091291XIA 3 SPINAL SYSTEM, UNIPLANNER/REDUCTION SCREWS & VITALLIUM RODNKB2009-06-24
37651899854934K090816STRYKER SPINE AVS PL PEEK SPACERSMAX2009-04-24
37651174225730K090166AVS ANTERIOR LARGE PEEK SPACERSMAX2009-04-22
37651608003953K083661AVS TL PEEK SPACERSMAX2009-02-27
37651381498642K083562STRYKER SPINE NULOCK ANTERIOR CERVICAL PLATING SYSTEMKWQ2009-03-25
37651856201911K083393XIA 3 SPINAL SYSTEMNKB2009-04-01
37652001028362K083020STRYKER SPINE REFLEX TRANSLATIONAL ANTERIOR CERVICAL PLATING SYSTEMKWQ2009-03-26
37651267176168K082608RADIUS SPINAL SYSTEM, VITALLIUM ROD #486613601NKB2008-10-07
37651443850462K082014STRYKER SPINE AVS PL PEEK SPACERSMAX2008-07-28
37651145980855K080928XIA SPINAL SYSTEM, STAINLESS STEEL UNI-PLANAR SCREWSNKB2008-04-30
37651722791554K080773THOR ANTERIOR PLATING SYSTEMKWQ2008-06-09
37651522289665K080758AVS PL PEEK SPACERS, MODELS 48351 AND 48353MAX2008-03-27
37651462312363K080143MODIFICATION TO STRYKER SPINE OASYS SYSTEMMNI2008-02-14
37651605999237K073470AVS PL PEEK SPACERS, MODELS 48351XXX AND 48353XXXMAX2008-03-06
37651683915639K073437THOR ANTERIOR PLATING SYSTEMKWQ2008-02-13
37651751888684K073151MANTIS SPINAL SYSTEMNKB2007-12-06
37651122903489K072568MODIFICATION TO OASYS SYSTEMKWP2007-10-05
37651011432352K071541SBI TWISTOFIXHWC2007-09-10
37651944145582K071540SBI TITANIUM THREADED PINJDW2007-08-08
37651561099151K071373STRYKER SPINE XIA III SPINAL SYSTEMNKB2007-08-27
37652000613114K070631DEVICE MODIFICATION TO RADIUS SPINAL SYSTEMNKB2007-07-13
37651251277257K070368TRIO PLATE SYSTEM, TRIO SPINAL FIXATION SYSTEM, TRIO+ SPINAL SYSTEMNKB2007-05-04
37651652314906K070031MEMOMETAL MEMORY STAPLESJDR2007-03-19
37651912613244K063430ZERO PROFILE ANTERIOR CERVICAL PLATE (ACP) SYSTEMKWQ2007-03-22
37651668403923K063428XIA STAINLESS STEEL SPINAL SYSTEMNKB2006-12-11
37651477090663K062853MODIFICATION TO STRYKER SPINE OASYS SYSTEMMNI2006-10-24
37651496080854K062698TRIO + SPINAL SYSTEMMNI2006-10-11
37651252701019K062310REFLEX HYBRID ACP SYSTEMKWQ2006-08-18
37651527294039K062270RADIUS SPINAL SYSTEMNKB2006-11-22
37651312124780K062132AVS PL PEEK SPACER SYSTEMMQP2006-08-16
37651964263760K061854XIA TITANIUM SPINAL SYSTEM AND XIA STAINLESS STEEL SPINAL SYSTEMNKB2006-07-27
37651992916593K061836AVS ASL PEEK SPACER SYSTEMMQP2006-08-03
37651669786087K061813MANTIS SPINAL SYSTEMMNH2006-09-19
37651616499086K060979XIA TITANIUM AND 4.5 SPINAL SYSTEMSNKB2006-05-19
37651564294476K060748MODIFICATION TO XIA 4.5 SPINAL SYSTEMNKB2006-04-13
37651393328075K060506STRYKER SPINE VLIFT VERTEBRAL BODY REPLACEMENT SYSTEMMQP2006-05-25
37651688862743K060361XIA SPINAL SYSTEM, XIA 4.5 SPINAL SYSTEMNKB2006-03-06
37651000085136K053115XIA SPINAL SYSTEMMNI2005-12-06
37651859807034K052971STRYKER SPINE TRIO SPINAL FIXATION SYSTEMMNI2005-11-16
37651091679533K052761MODIFICATION TO: XIA 4.5 SPINAL SYSTEMMNI2005-10-11
37651391834674K052576SBI AUTOFIXHWC2005-11-07
37651736460788K052317MODIFICATION TO: STRYKER SPINE OASYS SYSTEMMNI2005-09-21
37651049648201K052181MODIFICATION TO XIA SPINAL SYSTEMKWP2005-09-08
37651430847039K051973MODIFICATION TO: XIA STAINLESS STEEL SYSTEMKWP2005-08-18
37651425948508K051605SBI K-WIRESHTY2005-08-10
37651540576871K051205STRYKER SPINE AVS ASL PEEK SPACERMQP2005-11-04
37651321248435K050624STRYKER SPINE AVS PL PEEK SPACERMQP2005-04-11

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NKB302017-10-10
KWQ242017-08-23
KWP212015-06-09
MNH172010-03-18
MAX132019-07-25
MNI122008-02-14
MQP92009-09-25
OLO42019-05-17
ODP42016-07-15
JDR32016-07-26
OVD32015-01-26
NKG22015-07-09
HTY22011-11-17
HWC22007-09-10
HAW22001-12-03
FMF12016-07-08
PGM12014-10-27
ETN12014-07-01
FST12012-11-01
NQW12012-04-16
GXZ12011-07-28
OVE12011-04-22
JDW12007-08-08
HSB12004-01-15
MRW12003-08-22