FDA.reportPublic FDA data

Michelle Obenauer

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30147259043014725904Michelle Obenauer1N2027-01-01Medtronic Sofamor Danek Headquarters 1800 Pyramid Place Memphis TN US 38132
30117952353011795235Michelle Obenauer1N2026-01-011800 Pyramid Place Memphis TN US 38132

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2928031954472080P970015INTER FIX THREADED FUSION DEVICEMAX1999-05-14
2928031596660047P000058INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICENEK2002-07-02
2777891942544278K994122BONE GRAFT WASHER, MODEL 9090114 - 9090118KWQ2000-02-18
2777892018734928K993810CD HORIZON SPINAL SYSTEMMNH2000-02-03
2777891062976338K993021METRX SYSTEMHRX1999-11-10
2777891521473404K991528MODIFICATION TO TENOR SPINAL SYSTEM-ROD/BOLT CONNECTORMNH1999-05-28
2777891651344753K991364MODIFICATION TO TENOR SPINAL SYSTEM-PLATESMNH1999-05-19
2777891960338766K982990TSRH SPINAL SYSTEMMNI1998-10-21
2777891720810943K982490TENOR SPINAL SYSTEMKWP1998-10-05
2777891585121147K981676CD HORIZON SPINAL SYSTEMKWP1999-01-28
2777891154504240K964275ALPHA POSTERIOR SPINAL SYSTEMKWP1997-01-14
2777891846753732K962708TITANIUM CD HORIZON SPINAL SYSTEMKWP1997-02-06
2777891563922525K961633CD HORIZON SPINAL SYSTEMKWP1996-12-05
2777891157825981K955365COMPACT COTREL-DUBOUSSET (CCD) SPINAL SYSTEMKWP1996-03-27
2777891697709122K954645TITANIUM GDLH POSTERIOR SPINAL SYSTEMKWP1996-01-16
2777891937209296K943827SPINE FIXATIONMNH1996-02-14
2777891421175831K936294SENTRY(TM) ANTERIOR/POSTERIOR SPINAL SYSTEMSKWP1995-12-19
2777891163323272K934007SOFAMOR ORFIL SPINE FIXATION SYSTEMKWP1994-06-02
2777891948975328K922543Z-PLATE ANTERIOR FIXATION SYSTEMKWQ1993-05-19
2777891297978924K921767COMPACT COTREL -- DUBOUSSET SPINE SYSTEMKWP1993-06-22
2777891055677097K896254DANEK PRECISION ROD SETKWP1990-06-14
2777891995310122K892651SONGER WIRING SYSTEMLRN1989-07-25
2777891142760038K890601STUART TITANIUM SURGICAL MESHEZX1989-03-16
2777891931221290K880215TSRH H/M HOOK, EYEBOLT/LOCK NUT ASSEM., SPINAL RODKWP1988-02-18
2777891878931263K870830WARSAW ORTHOPEDIC TSR CROSS LINK SYSTEMKWP1987-05-04
2928031532493533K253381Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical applicationOLO2026-02-12
2928031730227813K241164IB3D™ PL Spinal SystemMAX2024-09-06
2777891750580087K221244CD Horizon™ Spinal SystemNKB2022-05-25
2777891540874902K210637CD Horizon™ Spinal SystemNKB2021-04-30
2777891230520440K210425Catalyft PL Expandable Interbody SystemMAX2021-05-24
2777891331270952K203678CD HORIZON™ Spinal SystemNQP2021-01-15
2777891091903597K202328CD Horizon Spinal SystemNKB2020-09-08
2777891548447528K201362CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone CementPML2020-08-19
2928031213819926K191066CD Horizon™ Astute™ Spinal SystemNQP2019-10-03
2928031455990889K190840Medtronic Transportation / Sterilization CassettesKCT2019-10-15
2928032021215784K190165Capstone Control™ Spinal SystemMAX2019-05-06
2777891876081027K183197PYRAMESH™ Implant SystemMQP2019-04-04
2777891989444160K182928CD Horizon™ Spinal SystemNQP2019-01-11
2928031989444160K182928CD Horizon™ Spinal SystemNQP2019-01-11
2777891838033547K182119CD HORIZON™ Spinal SystemNKB2018-08-29
2777891250773589K181111Navigated INFINITY InstrumentsOLO2018-05-17
2777892034785122K180851VERTEX™ Reconstruction SystemNKG2018-04-18
2777891651626048K173338Navigated INFINITY™ InstrumentsOLO2018-01-18
2777891797154304K173249CD HORIZON™ Spinal SystemNKB2018-03-08
2928031339363098K172328SOVEREIGN™ Spinal SystemOVD2017-11-02
2928031817281054K172199ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System TitaniumMAX2017-09-19
2777891817281054K172199ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System TitaniumMAX2017-09-19
2928031850486800K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemMAX2017-09-26
2928031863295055K171031CRESCENT™ Spinal SystemMAX2017-07-06
2777891784330798K170679CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION® and IPC® POWEREASE® SystemsNKB2017-05-11
2777891354897996K163375INFINITY™ OCT SystemNKG2017-08-21
2928031354897996K163375INFINITY™ OCT SystemNKG2017-08-21
2777891284188901K163301CD HORIZON® Spinal SystemNKB2016-12-20
2777891638685216K162379CD HORIZON® Spinal SystemNKB2016-11-16
2777891406628358K161210RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC(TM) Powerease(TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation(TM) and IPC(TM) Powerease(TM) SystemsOUR2016-08-12
2777891495968501K152604KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetPML2016-01-06
2777891575494230K152277PIVOX(tm) Oblique Lateral Spinal SystemMAX2015-11-13
2928031575494230K152277PIVOX(tm) Oblique Lateral Spinal SystemMAX2015-11-13
2777891711325177K150200CD HORIZON Growth Rod Conversion SetPGM2015-02-25
2777891457491831K150178CD HORIZON SPINAL SYSTEMNKB2015-02-11
2928031148579273K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMAX2015-06-11
2777891148579273K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMAX2015-06-11
2777892026793275K143628Navigated Vertex Select InstrumentsOLO2015-02-12
2777891050839240K143569CD HORIZON Spinal SystemNKB2015-02-12
2777891575329434K143471VERTEX Reconstruction SystemNKG2015-02-06
2777891237561095K143375CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsNKB2015-02-13
2777891518806281K143141CD HORIZON Spinal SystemNKB2014-12-01
2777891118348448K142847CD HORIZON Spinal SystemNKB2014-10-27
2777891079515545K142591CD HORIZON Spinal SystemNKB2014-12-01
2777891014487377K142559ELEVATE Spinal SystemMAX2015-06-09
2777892043048987K141632ZEVO (TM) ANTERIOR CERVICAL PLATE SYSTEMKWQ2014-12-04
2777891040552438K141604CD HORIZON SPINAL SYSTEMNKB2014-10-21
2928031951448746K141599DIVERGENCE ANTERIOR CERVICAL FUSION SYSTEMOVE2015-01-21
2928031441322248K140417DIVERGENCE MINI-PLATE ANTERIOR CERVICAL FUSION SYSTEMKWQ2014-07-09
2777891441322248K140417DIVERGENCE MINI-PLATE ANTERIOR CERVICAL FUSION SYSTEMKWQ2014-07-09
2928031017160543K133653ANATOMIC PEEK PTC CERVICAL FUSION SYSTEMODP2014-04-28
2928031467469001K133650CAPSTONE SPINAL SYSTEMMAX2013-12-20
2928031486539884K133205CAPSTONE PTC SPINAL SYSTEM, CLYDESDALE PTC SPINAL SYSTEMMAX2014-03-13
2928032052746260K132897CLYDESDALE SPINAL SYSTEMMAX2013-12-11
2777891913540412K132639CD HORIZON SPINAL SYSTEMNKB2013-11-25
2777891201482246K132471CD HORIZON SPINAL SYSTEMNKB2013-10-08
2777891141974572K132328CD HORIZON SPINAL SYSTEMNKB2013-12-06
2777891483076437K132111CD HORIZON SPINAL SYSTEMNKB2013-08-06
2777891074638674K131321CD HORIZON SPINAL SYSTEMOSH2013-06-05
2777891084304972K130646CD HORIZON SPINAL SYSTEMNKB2013-04-10
2928031936499547K130335MASTERGRAFT STRIP; MASTERGRAFT ULTRAMATRIXMQV2013-04-19
2928031597581382K123978CAPSTONE L SPINAL SYSTEMMAX2013-04-09
2777891691491711K123906VERTEX RECONSTRUCTION SYSTEM, VERTEXT SELECT RECONSTRUCTION SYSTEMKWP2013-04-01
2777891739021395K123656VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEMKWP2013-02-25
2777891110411279K122862CD HORIZON SPINAL SYSTEMNKB2012-10-03
2928031907016967K121982SOVEREIGN SPINAL SYSTEMOVD2012-07-26
2928031527732545K121760CAPSTONE SPINAL SYSTEMMAX2012-08-29
2777891322948516K121680CD HORIZON SPINAL SYSTEMNKB2012-07-05
2928032015014199K120368CAPSTONE CONTROL SPINAL SYSTEMMAX2012-04-09
2928031406234113K113528CLYDESDALE(R) SPINAL SYSTEMMAX2011-12-20
2928031057877703K113252PEEK PREVAIL CERVICAL INTERBODY DEVICEOVE2012-01-17
2777891839067739K113174CD HORIZON SPINAL SYSTEMNKB2011-11-21
2928031061452244K112444ANATOMIC PEEK CERVICAL FUSION SYSTEMODP2011-11-15
2928031887305584K112405CLYDESDALES SPINAL SYSTEMMAX2011-11-21
2777891714155627K111942TSRH SPINAL SYSTEMSNKB2011-08-30
2928031766863426K111264CORNERSTONE (R) PSR CERVICAL FUSION SYSTEMODP2011-10-12
2928031440749277K110562TELAMON PEEK SPINAL SYSTEMMAX2011-11-09
2928031004936373K110063SOVEREIGN SPINAL SYSTEMOVD2011-10-04
2777891004936373K110063SOVEREIGN SPINAL SYSTEMOVD2011-10-04
2777891102123829K103049TSRH SPINAL SYSTEMNKB2010-12-23
2777891244857142K102555CD HORIZON SPINAL SYSTEMNKB2010-11-17
2777892056902649K101772TSRH(R) SPINAL SYSTEMNKB2010-09-30
2777891768070609K101074MODIFICATION TO: CD HORIZON(R) SPINAL SYSTEMNKB2010-06-22
2928031536587307K100967PERIMETER C SPINAL SYSTEMODP2011-08-05
2928031868668279K100214CORNERSTONE PSR CERVICAL INTERBODY FUSION DEVICEODP2010-06-25
2928031019915864K100175CLYDESDALE SPINAL SYSTEMMAX2010-06-02
2928031959190979K094042PEEK PREVAIL CERVICAL INTERBODY DEVICEOVE2010-06-30
2928031894606593K094025CRESCENT SPINAL SYSTEMMAX2010-04-26
2777891791928614K093058TSRH SPINAL SYSTEMNKB2009-10-26
2777891519182230K092676TSRH SPINAL SYSTEMNKB2009-10-02
2777891977828848K092325MODIFICATION TO:CD HORIZON SPINAL SYSTEMNKB2009-12-15
2777891655316461K091974MODIFICATION TO CD HORIZON SPINAL SYSTEMNKB2009-09-02
2928031494500234K091813INTREPID SPINAL SYSTEMOVD2009-11-17
2777891494500234K091813INTREPID SPINAL SYSTEMOVD2009-11-17
2777891777858086K091365VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEMKWP2009-08-06

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NKB482022-05-25
KWP382013-04-01
MAX282024-09-06
MQP192019-04-04
KWQ142014-12-04
MNI122006-01-05
MNH82001-04-11
OVD62017-11-02
ODP52014-04-28
OLO42026-02-12
NQP42021-01-15
NKG42018-04-18
OVE42015-01-21
MQV32013-04-19
PML22020-08-19
KCT12019-10-15
OUR12016-08-12
PGM12015-02-25
OSH12013-06-05
LYC12009-01-09
NQW12005-06-06
GAD12005-02-23
NEK12002-07-02
JDK12001-10-10
MRW12001-01-17
HRX11999-11-10
LRN11989-07-25
EZX11989-03-16