FDA.reportPublic FDA data

Medtronic, Inc - Philadelphia Distribution Center

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30070269063007026906Medtronic, Inc - Philadelphia Distribution Center1N2020-04-251130 Commerce Blvd Ste 110 Swedesboro NJ US 08085

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
861521791905019K994239ZEPHIR ANTERIOR CERVICAL PLATE SYSTEMKWQ2000-06-19
861521331165389K993855ATLANTIS ANTERIOR CERVICAL PLATE SYSTEMKWQ1999-12-15
861521062976338K993021METRX SYSTEMHRX1999-11-10
861521283829531K992928CD HORIZON SPINAL SYSTEMMNI1999-09-21
861521999960604K992110PREMIER ANTERIOR CERVICAL PLATE SYSTEMKWQ1999-09-14
861521521473404K991528MODIFICATION TO TENOR SPINAL SYSTEM-ROD/BOLT CONNECTORMNH1999-05-28
861521015159206K991460MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEMMNH1999-05-19
861521651344753K991364MODIFICATION TO TENOR SPINAL SYSTEM-PLATESMNH1999-05-19
861521687414764K991198DYNA-LOK PLUS SPINAL SYSTEMKWP1999-08-27
861521010808771K991036DANEK PLATE AND SCREW SYSTEMMNH1999-09-14
861521490627623K991031COLORADO II SPINAL SYSTEMMNH2000-05-10
861522002677408K990603MODIFICATION OF THE ZPLATE-ATL ANTERIOR FIXATION SYSTEMKWQ1999-03-10
861521258968485K984522MODIFICATION OF TSRH SPINAL SYSTEMMNI1999-01-06
861521387689553K984360COLORADO II SPINAL SYSTEMMNH2000-03-30
861521960338766K982990TSRH SPINAL SYSTEMMNI1998-10-21
861522068018505K982875MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEMKWQ1999-01-19
861521720810943K982490TENOR SPINAL SYSTEMKWP1998-10-05
861521537207222K980184CD SPINAL SYSTEMMNI1998-12-18
861521971712798K973854ORION ANTERIOR CERVICAL PLATE SYSTEMKWQ1998-03-16
861521576003066K973011BPX80 BIO-PUMP (BPX80)KFM1998-02-25
861521736191801K970806ACPII ANTERIOR CERVICAL PLATE SYSTEMKWQ1997-05-02
861521891189775K965193LIBERTY ANTERIOR SPINAL SYSTEMKWQ1997-03-17
861521790811986K964623TITANIUM CD HORIZON ANTERIOR SPINAL SYSTEMKWQ1997-02-06
861521806894514K964254TITANIUM LIBERTY POSTERIOR SPINAL SYSTEMKWP1997-04-21
861521412875585K964159CD SPINAL SYSTEMKWP1997-10-16
861521462676179K963655CD HORIZON ANTERIOR SPINAL SYSTEMKWQ1996-11-27
861521373748860K963642INCL II ENDOSCOPEGWG1998-03-18
861521563922525K961633CD HORIZON SPINAL SYSTEMKWP1996-12-05
861521043362474K955807COTREL-DUBOUSSET (CD) SPINALKWP1996-10-01
861521642468742K955471INCL ENDOSCOPEHRX1995-12-18
861521697709122K954645TITANIUM GDLH POSTERIOR SPINAL SYSTEMKWP1996-01-16
861521706553644K951164CD LIBERTY POSTERIOR SPINCAL SYSTEMKWP1996-02-09
861521596499608K950955PARAGON POSTERIOR SPINAL SYSTEMMNH1995-08-25
861521089783813K950717AUGMENT-T POSTERIOR SPINAL SYSTEMMNH1996-02-14
861521726152151K950596GDLH POSTERIOR SPINAL SYSTEMMNH1995-08-28
861521256492282K950501DANEK RIGID ARTHROSCOPEHRX1995-05-12
861521138758898K950130MICRO-ENDO(TM) INSTRUMENTSHRX1995-05-01
861521277445944K946348TITANIUM TSRH(R) SPINAL SYSTEM (SCREWS)MNH1995-08-07
861521367893110K946087INCLUSICE II(TM) ENDOSCOPEHRX1995-11-21
861521744379142K945022APOFIX CERVICAL SPINE FIXATIONKWP1995-05-15
861521937209296K943827SPINE FIXATIONMNH1996-02-14
861521538231040K943356INCLUSIVE ENDOSCOPEHRX1995-05-10
861521421175831K936294SENTRY(TM) ANTERIOR/POSTERIOR SPINAL SYSTEMSKWP1995-12-19
861521298784237K934582GDLH VARIABLE ANGLE CONNECTORKWP1994-06-21
861521375419596K933242SOFAMOR ORTHOPAEDIC INSTRUMENTSLXH1994-01-28
861521260853652K933205TSRH(R) TOP TIGHT T-BOLT-VARI ANGLE/SCREW/PARAGONKWP1994-05-04
861521340568189K932029TSRH SPINAL SCREWSMNH1995-01-20
861521291644670K930807SENTRY ANTERIOR SPINAL SYSTEMKWQ1993-10-01
861521190629329K930710SENTRY POSTERIOR SPINAL SYSTEMKWP1993-10-01
861521845030859K930191DANEK(TM) SPINAL EPIDURAL ENDOSCOPIC SYHRX1995-09-26
861521413631021K925812TITANIUM SONGER CABLE SYSTEMJDQ1993-03-24
861521935086727K925811TSRH CENTRAL POST HOOKSKWP1993-05-18
861521651956966K923339TSRH L CONNECTOR -- MODIFICATIONKWP1992-10-27
861521106019015K923242CROSSLINK AXIAL AND OFFSET PLATESKWQ1993-05-19
861521948975328K922543Z-PLATE ANTERIOR FIXATION SYSTEMKWQ1993-05-19
861521770145259K922520MODIFIED TSRH CENTRAL POST HOOKSKWP1992-11-16
861521577722432K922087ANTERIOR CERVICAL PLATE SYSTEMKWQ1992-11-06
861521877544524K921256LUQUE V SPINAL SYSTEMKWP1993-05-18
861521486172647K921056COTREL - DUBOUSSET SPINE IMPLANTSKWP1993-06-24
861521214293967K920546PARAGON POSTERIOR SPINAL SYSTEMKWP1993-01-21
861521842072482K920201TITANIUM ALLOY SONGER CABLE SYSTEMJDQ1992-04-08
861521782021626K914966TSRH CENTRAL POST HOOKSKWP1992-05-12
861521134038528K914306TSRH(TM) LATERAL OFFSET PLATEKWP1992-06-19
861521828362597K913735SONGER(TM) CABLE SYSTEMJDQ1991-11-18
861521210593809K911729DANEKSCOPE AND ACCESSORIESHRX1993-04-05
861522070046687K911379DANEK SACRAL HOOK, MODIFICATIONKWP1991-09-11
861521805456335K911319TSRH OPEN HEAD BONE SCREWKWP1991-09-06
861521221658478K911307CROSSLINK PLATEKWP1991-10-24
861521940182379K911300MICROSURGICAL INSTRUMENTSHRX1991-04-05
861521790335540K904520RAY SACRAL FIXATION SYSTEMKWP1991-10-25
861522025414617K904243TSRH VARIABLE ANGLE SACRAL SCREWKWP1992-01-22
861521952537913K903676STERNOTOMY CABLE, SONGER CABLE SYSTEMJDQ1990-09-10
861521505392034K903461TSRH OFFSET AND SIDE-LOADING HOOKSKWP1990-12-05
861521820196329K902775KNIGHT SACRAL SCREWKWP1990-12-10
861521477588614K901692DANEK SPINALSCOPEHRX1992-02-14
861521881050248K901590DANEK SACRAL HOOKKWP1990-08-21
861522004900606K901587TSRH SACRAL L-CONNECTORKWP1990-11-05
861521815218858K901005TSRH SPINAL SYSTEM (ADD'L SIZES OF HOOKS)KWP1990-12-10
861521835346380K897141SLOT STAPLES AND ADAPTOR FOR ZIELKE SPINAL FIXATIOJDN1990-06-21
861521069263046K896740AXIAL AND OFFSET CROSSLINK PLATESKWP1990-02-26
861522035686174K896603HSC UNIT RODKWP1990-01-30
861521055677097K896254DANEK PRECISION ROD SETKWP1990-06-14
861521156204346K895978CHIBA SPINAL SYSTEMKWP1990-08-09
861521995310122K892651SONGER WIRING SYSTEMLRN1989-07-25
861521142760038K890601STUART TITANIUM SURGICAL MESHEZX1989-03-16
861521170044370K890192LUQUE III SPINAL SYSTEM AND LUQUE MINI-SETKWP1990-01-04
861521756097420K883784TSRH ANTERIOR SPINAL SCREWS, STAPLES AND END PLATELYQ1989-04-06
861521042133273K883783TSRH SACRAL SPINAL SCREWKWP1989-04-06
861521931221290K880215TSRH H/M HOOK, EYEBOLT/LOCK NUT ASSEM., SPINAL RODKWP1988-02-18
861521953015575K880214TSRH H/M TORQUE LIMITING WRENCHKWP1988-02-18
861522066642749K880212TSRH H/M HOOK HOLDER W/ROD MOVERKWP1988-03-04
861521522615776K880211TSRH H/M HOOK HOLDERKWP1988-03-04
861521878931263K870830WARSAW ORTHOPEDIC TSR CROSS LINK SYSTEMKWP1987-05-04
861521021642879K862311SCREW DRIVER/BONE SCREW WRENCH/TAP & GUIDE PINKTT1986-07-25
861521994578308K862230WARSAW ORTHOPEDIC CANCELLOUS BONE SCREWHWC1986-08-29
861521721291131K843445SACRAL BARKWP1985-02-13
861521867758360K830735BT 795/A AUTOTRANSCAC1983-05-02
861521416146925K800178EXTRACORP.'S INTERSEPT CUS. TUBING PK.DWE1980-02-21
861521907016967K121982SOVEREIGN SPINAL SYSTEMOVD2012-07-26
861521052122011K121764CD HORIZON SPINAL SYSTEMNKB2012-08-21
861521527732545K121760CAPSTONE SPINAL SYSTEMMAX2012-08-29
861521322948516K121680CD HORIZON SPINAL SYSTEMNKB2012-07-05
861521568067124K112473CD HORIZON SPINAL SYSTEMNKB2011-10-21
861521563697438K110522VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEMKWP2011-04-01
861521790080734K110070TSRH SPINAL SYSTEMNKB2011-06-08
861521004936373K110063SOVEREIGN SPINAL SYSTEMOVD2011-10-04
861521102123829K103049TSRH SPINAL SYSTEMNKB2010-12-23
861521580638816K102807CD HORIZON SPINAL SYSTEMNKB2010-11-17
861521244857142K102555CD HORIZON SPINAL SYSTEMNKB2010-11-17
861522056902649K101772TSRH(R) SPINAL SYSTEMNKB2010-09-30
861521536587307K100967PERIMETER C SPINAL SYSTEMODP2011-08-05
861521337801374K093434VERTEX RECONSTRUCTION SYSTEM AND VERTEX SELECT RECONSTRUCTION SYSTEMNKB2009-12-02
861521791928614K093058TSRH SPINAL SYSTEMNKB2009-10-26
861521519182230K092676TSRH SPINAL SYSTEMNKB2009-10-02
861521655316461K091974MODIFICATION TO CD HORIZON SPINAL SYSTEMNKB2009-09-02
861521627760777K091883T2 SPINAL SYSTEMMQP2009-09-21
861521433318163K091797TSRH SPINAL SYSTEMNKB2010-04-30
861521778264866K091442CD HORIZON SPINAL SYSTEMNKB2009-07-15
861521370524533K090740MODIFICATION TO: TSRH SPINAL SYSTEMNKB2009-08-14
861521743067319K090714VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEMKWP2009-04-17

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KWP712011-04-01
KWQ302008-08-15
NKB282012-08-21
MNH222006-07-25
MQP202009-09-21
MNI162006-12-22
HRX112000-11-24
MAX52012-08-29
JDQ41993-03-24
OVD22012-07-26
ODP12011-08-05
NQW12005-06-06
GAD12005-02-23
GWG11998-03-18
KFM11998-02-25
LXH11994-01-28
JDN11990-06-21
LRN11989-07-25
LYQ11989-04-06
EZX11989-03-16
HWC11986-08-29
KTT11986-07-25
CAC11983-05-02
DWE11980-02-21