FDA.reportPublic FDA data

ZIMMER BIOMET SPINE. INC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30091741793009174179ZIMMER BIOMET SPINE. INC1Y2020-04-255400 Meltech Blvd Ste 119 Memphis TN US 38118

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1316291152862405P950002BAK INTERBODY FUSION SYSTEMMAX1996-09-20
1316291478061994K990005SPINAL CONCEPTS, INC. (SCI) ANTERIOR CERVICAL PLATE SYSTEMKWQ1999-02-12
1316291307662820K984578SYNERGY D2 SPINAL IMPLANTSMNI1999-03-23
1316291454994467K974020SPINAL CONCEPTS, INC., CFIX CABLE SYSTEMJDQ1997-12-19
1316291141445743K973836SYNERGY 6.35MM SS ROD WITH SCREWS FOR ANTERIOR USE, PART OF THE CROSS MEDICAL-SYNERGY ANTERIOR SPINAL SYSTEMMNH1998-03-05
1316291808351126K964404BACFIX SPINAL FIXATION SYSTEMKWP1997-03-26
1316291057687112K950709SYNERGY TI ANTERIOR SPINAL SYSTEMKWQ1995-10-25
1316292073452421K950099SYNERGY(TM) TI POSTERIOR SPINAL SYSTEMMNH1997-01-16
1316291157881906K150896Vitality Spinal Fixation SystemNKB2015-08-31
1316291623513674K141804POLARIS SPINAL SYSTEM - HA COATEDNKB2014-09-25
1316291971630503K141791BIOMET FUSION SYSTEMOVD2014-10-09
1316291579077774K141500OPTIO-C ANTERIOR CERVICAL SYSTEMKWQ2014-09-23
1316291949839651K140734NEXTGEN ALTIUS OCT SYSTEMKWP2014-12-15
1316291821438810K140123POLARIS SPINAL SYSTEM -TRANSLATION SCREWNKB2014-04-24
1316291406584733K133796NEXSITE HD, HEMODIALYSIS CATHETER FOR LONG TERM USE (32CM), NEXSITE HD, HEMODIALYSIS CATHETER FOR LONG TERM USE (36CM),MSD2014-01-31
1316291897611285K133746POLARIS SPINAL SYSTEMNKB2014-03-12
1316291272141338K133556VIRAGE OCT SPINAL FIXATION SYSTEMKWP2014-06-02
1316291857192922K133518MAXAN ANTERIOR CERVICAL PLATE SYSTEMKWQ2014-11-05
1316292053301907K133291ST360 DEGREES SPINAL FIXATION SYSTEMNKB2013-12-17
1316292047669271K133184ARDIS INTERBODY SYSTEMMAX2014-01-30
1316292024604763K133086TITLE 2 POLYAXIAL SPINAL SYSTEMNKB2013-11-27
1316291217532554K132884PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEMNKB2013-11-25
1316292040737161K132790INFIX ANTERIOR LUMBAR SYSTEMMAX2013-12-20
1316291803463117K132012TRINICA(R) ANTERIOR CERVICAL PLATE SYSTEM, TRINICA(R) SELECT ANTERIOR CERVICAL PLATE SYSTEMKWQ2013-08-29
1316291652382819K131980SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEMNKB2013-09-04
1316291898132362K131547LANX FUSION SYSTEMOVD2013-07-12
1316291353913725K131156LANX SPINAL FIXATION SYSTEMKWP2013-05-24
1316291137341811K123767LANX FUSION SYSTEM- SAOVD2013-03-18
1316291403877115K123549POLARIS SPINAL SYSTEM - BALLISTA II PERCUTANEOUS SCREW PLACEMENT SYSTEMNKB2013-02-25
1316291781805913K123451POLARIS SPINAL SYSTEM - BALLISTA II RODSNKB2012-12-03
1316292062663647K122733V2F ANTERIOR FIXATION SYSTEMKWQ2012-12-07
1316291799679803K122378NEXTGEN ALTIUS OCT SYSTEMKWP2012-09-20
1316291527010207K122145LANX SPINAL FIXATION SYSTEMNKB2012-08-17
1316291468794151K121316LANX SPINAL FIZATION SYSTEMNKB2012-09-10
1316291971546705K121130POLARIS SPINAL SYSTEM-BALLISTA SPINAL RODSNKB2012-06-15
1316291656621897K120399LANX SPINAL FIXATION SYSTEMNKB2012-03-09
1316291378384855K113593NEXTGEN ALTIUS OCT SYSTEMKWP2012-04-17
1316292044814496K113434LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)NKB2011-12-19
1316291093050855K112388LANX CERVICAL SAOVE2011-12-16
1316291764816622K111957POLARIS SPINAL SYSTEMNKB2011-08-19
1316291788137540K111796INVIZIA ANTERIOR CERVICAL PLATE SYSTEMKWQ2011-10-27
1316291273971225K103666LANX LATERALMAX2011-03-23
1316291512913980K103660LANX CERVICAL INTERVERTEBRAL BODY FUSION SYSTEMODP2011-02-28
1316291496648666K103393POLARIS SPINAL SYSTEMKWQ2011-02-02
1316291518881512K103237LANX SPINAL SYSTEMNKB2011-03-25
1316291747006549K103040LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)NKB2011-02-08
1316291277781751K102738LANX FUSION SYSTEMOVD2011-02-10
1316292019324679K101364LANX FACET SCREW SYSTEMMRW2010-08-16
1316291968787763K100888MODIFICATION TO LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEMKWP2010-11-15
1316291055286862K100845PATHFINDER II, MINIMALLY INVASIE PEDICLE SCREW SYSTEM MODEL 3500 SERIESNKB2010-09-21
1316291399147741K100805GALLERY LAMINOPLASTY FIXATION SYSTEMNQW2010-07-20
1316291014473817K100438POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTURE ANTERIOR FIXATION SYSTEMNKB2010-06-23
1316291065076423K100409POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTUE ANTERIOR FIXATION SYSTEMNKB2010-06-23
1316291453548813K100220POLARIS SPINAL SYSTEMNKB2010-05-17
1316291147961801K100191LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)KWP2010-04-15
1316291015695022K093285MODIFICATION TO LANX SPINAL FIXATION SYSTEMMNI2009-12-10
1316291690186097K092765LANX ANTERIOR PLATING SYSTEMKWQ2010-04-07
1316291116062839K092656LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEMKWP2009-11-24
1316291777467431K092574ESL SPINAL SYSTEMMAX2010-02-04
1316291459451470K092536SPINAL FIXATION SYSTEMNKB2009-10-30
1316291173736538K091381IBEX SPINAL SYSTEMMAX2009-08-07
1316291222348771K0910675.5 POLARIS SPINAL SYSTEMNKB2009-07-14
1316291771197855K090523POLARIS SPINAL SYSTEMNKB2009-07-01
1316291506839004K090316MODIFICATION TO: LANX ANTERIOR CERVICAL PLATE SYSTEMKWQ2009-04-07
1316291519370572K090060NEXLINK OCT SYSTEM, MODEL 7000 SERIESKWP2009-06-02
1316291195815869K082774LANX CERVICAL INTERVERTEBRAL BODY FUSION DEVICEMAX2008-10-21
1316291973842718K082187BIOMET ANTERIOR LUMBAR PLATEKWQ2008-11-13
1316291002148627K081952SYNERGY SPINAL SYSTEM (6.35 POLARIS)NKB2008-10-07
1316291449826192K081501SOLITAIRE ANTERIOR SPINAL SYSTEMOVD2008-07-02
1316291808302765K080646C-TEK MAXAN ANTERIOR CERVICAL PLATE SYSTEMKWQ2008-05-02
1316291093931863K073144LANX INTERVERTEBRAL BODY FUSION DEVICEMAX2008-01-24
1316291670002777K071905POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)KWQ2007-12-28
1316291195880230K071633LANX DEFORMITY SYSTEMKWP2007-08-15
1316292034822632K071377POLARIS BE RODSKWP2007-08-06
1316291736326677K071174PATHFINDER SYSTEM POLYAXIAL PEDICLE SCREWSNKB2007-07-25
1316291593034466K070282ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEMNKB2007-09-06
1316291410162685K062505NEX-LINK SPINAL FIXATION SYSTEM OFFSET CONNECTORS, 2121-XX SERIESMNI2006-09-26
1316291006873693K061563EBI ARRAY SPINAL SYSTEMNKB2006-06-23
1316291393335113K061441EBI 5.5 HELICAL FLANGE SPINAL SYSTEMMNH2006-07-25
1316291077290239K061353TRINICA ANTERIOR LUMBAR PLATE SYSTEMKWQ2006-08-30
1316291646267267K061345MODIFICATION TO ENDIUS ATAVI SYSTEMHRX2006-06-06
1316291995162443K060683ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEMKWP2006-04-18
1316291754135309K060634NEX-LINK SPINAL FIXATION SYSTEM ROD TO ROD CONNECTORS, MODELS 725, 726 SERIESMNI2006-03-31
1316291152114212K052384LANX VBR SYSTEMMQP2005-10-07
1316291682918176K052072THE SC-ACUFIX ANT-CER DYNAMIC CERVICAL PLATE SYSTEM SINGLE LEVEL PLATESKWQ2005-08-29
1316291262489439K043229MODIFICATION TO ALTIUS OCT SYSTEMKWP2004-12-21
1316291912468866K041794C-TEK C-THRU ANTERIOR CERVICAL PLATE SYSTEMKWQ2004-07-19
1316291377245045K041449SYNERGY HELICAL FLANGE PLUG, HELICAL FLANGE SEAT AND HELICAL FLANGE REDUCTION SEATKWP2004-07-01
1316291757112810K033961ALTIUS OCT SYSTEMKWP2004-04-14
1316291897143583K033312EBI TOP LOADING MAS SPINAL FIXATION SYSTEMNKB2004-01-13
1316291651321117K031985SPINAL CONCEPTS INC. NEX-LINK SPINAL FIXATION SYSTEMMNI2003-09-11
1316291586969733K031672SPINAL CONCEPTS, INC. INFIX SYSTEMMQP2003-08-07
1316291628038382K031355EBI SPINELINK - II SPINAL FIXATION SYSTEMNKB2003-07-22
1316291256903695K030625SPINAL CONCEPTS INC. PATHFINDERNKB2003-03-28
1316291250610979K030087SPINAL CONCEPTS, INC. BACFIX TI SPINAL SYSTEMNKB2003-07-17
1316291842911675K024326SPINAL CONCEPTS, INC. ANT-CER DYNAMIC ANTERIOR CERVICAL PLATE SYSTEMKWQ2003-01-23
1316291330564578K023644MODIFICATION TO INCOMPASS SPINAL FIXATION SYSTEMMNI2002-11-25
1316291531052722K023133MODIFICATION TO EBI VUELOCK ANTERIOR CERVICAL PLATE SYSTEMKWQ2002-10-18
1316291813775365K022374CADENCE SPINAL FIXATION SYSTEMKWP2002-09-24
1316291997801684K022048INTERPORE CROSS INTERNATIONAL (ICI) OCCIPITO-CERVICO-THORACIC (OCT) ROD AND PLATE SYSTEMKWP2002-12-04
1316291352839550K021881ENDIUS TITLE SPINAL FIXATION SYSTEMMNH2002-07-29
1316291829855682K021564INCOMPASS SPINAL FIXATION SYSTEMKWQ2002-10-25
1316291016945718K021009OCTAFIX OCCIPITAL CERVICAL PLATING SYSTEMKWP2002-06-18
1316291190992439K013979SC-ACUFIX THINLINE ANTERIOR CERVICAL PLATE SYSTEMKWQ2002-02-13
1316291393455332K013887BACFIX SPINAL FIXATION SYSTEMMNH2002-02-12
1316291738315240K012305MODIFICATION TO: TRINICA ANTERIOR CERVICAL PLATE SYSTEMKWQ2001-08-22
1316292019820818K011437SYNERGY 4.0 MM, 4.5 MM VLS SCREWSMNI2001-06-06
1316292068964666K010563END-TO-END AND SIDE-BY-SIDE CONNECTORSMNI2001-05-25
1316291059044371K010515MODIFICATION TO SYNERGY SPINAL SYSTEMKWP2001-03-22
1316291563367109K010003EBI VUELOCK ANTERIOR CERVICAL PLATE SYSTEMKWQ2001-01-31
1316291868423227K002980MODIFICATION TO EBI ANTERIOR CERVICAL PLATE SYSTEMKWQ2000-10-23
1316291464379581K002592INTERPORE CROSS ANTERIOR CERVICAL PLATE SYSTEMKWQ2000-10-06
1316291822134608K002082SPEEDLINK TRANSVERSE CONNECTORKWP2000-10-06
1316291152486208K001794EBI ANTERIOR CERVICAL PLATE SYSTEMKWQ2000-07-12
1316291845764920K000876SYNERGY ADJUSTABLE TRANSVERSE CONNECTOR ROD, SYNERGY ADJUSTABLE TRANSVERSE CONNECTOR LAMPMNI2000-04-18
1316291010382772
1316291069335971
1316291100018149
1316291113285235
1316291163477802

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NKB332015-08-31
KWQ252014-11-05
KWP212014-12-15
MNI92009-12-10
MAX72014-01-30
OVD52014-10-09
MNH52006-07-25
MQP22005-10-07
MSD12014-01-31
OVE12011-12-16
ODP12011-02-28
MRW12010-08-16
NQW12010-07-20
HRX12006-06-06
JDQ11997-12-19
MAX 11996-09-20