FDA.reportPublic FDA data

Michelle Obenauer

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
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
2928031532493533K253381Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical applicationOLO2026-02-12
2928031730227813K241164IB3D™ PL Spinal SystemMAX2024-09-06
2928031213819926K191066CD Horizon™ Astute™ Spinal SystemNQP2019-10-03
2928031455990889K190840Medtronic Transportation / Sterilization CassettesKCT2019-10-15
2928032021215784K190165Capstone Control™ Spinal SystemMAX2019-05-06
2928031989444160K182928CD Horizon™ Spinal SystemNQP2019-01-11
2928031339363098K172328SOVEREIGN™ Spinal SystemOVD2017-11-02
2928031817281054K172199ELEVATE 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
2928031354897996K163375INFINITY™ OCT SystemNKG2017-08-21
2928031575494230K152277PIVOX(tm) Oblique Lateral Spinal SystemMAX2015-11-13
2928031148579273K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMAX2015-06-11
2928031951448746K141599DIVERGENCE ANTERIOR CERVICAL FUSION SYSTEMOVE2015-01-21
2928031441322248K140417DIVERGENCE 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
2928031936499547K130335MASTERGRAFT STRIP; MASTERGRAFT ULTRAMATRIXMQV2013-04-19
2928031597581382K123978CAPSTONE L SPINAL SYSTEMMAX2013-04-09
2928031907016967K121982SOVEREIGN SPINAL SYSTEMOVD2012-07-26
2928031527732545K121760CAPSTONE SPINAL SYSTEMMAX2012-08-29
2928032015014199K120368CAPSTONE CONTROL SPINAL SYSTEMMAX2012-04-09
2928031406234113K113528CLYDESDALE(R) SPINAL SYSTEMMAX2011-12-20
2928031057877703K113252PEEK PREVAIL CERVICAL INTERBODY DEVICEOVE2012-01-17
2928031061452244K112444ANATOMIC PEEK CERVICAL FUSION SYSTEMODP2011-11-15
2928031887305584K112405CLYDESDALES SPINAL SYSTEMMAX2011-11-21
2928031766863426K111264CORNERSTONE (R) PSR CERVICAL FUSION SYSTEMODP2011-10-12
2928031440749277K110562TELAMON PEEK SPINAL SYSTEMMAX2011-11-09
2928031004936373K110063SOVEREIGN SPINAL SYSTEMOVD2011-10-04
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
2928031494500234K091813INTREPID SPINAL SYSTEMOVD2009-11-17
2928031370524533K090740MODIFICATION TO: TSRH SPINAL SYSTEMNKB2009-08-14
2928031608650094K090353PERIMETER INTERBODY FUSION DEVICEMAX2009-09-29
2928031593673758K083026CLYDESDALE SPINAL SYSTEMMAX2008-12-29
2928031715054451K082918MASTERGRAFT RESORBABLE CERAMIC GRANULESMQV2009-02-09
2928032052341061K082917MASTERGRAFT RESORBABLE CERAMIC GRANULESLYC2009-01-09
2928031637268244K080083INTREPID SPINAL SYSTEMMAX2008-04-10
2928031852515669K073291CAPSTONE SPINAL SYSTEMMAX2008-04-24
2928031986541277K073285PEEK PREVAIL CERVICAL INTERBODY DEVICEOVE2008-05-15
2928031274413678K070173VERTE-STACK SPINAL SYSTEMMQP2007-03-14
2928032058530107K062133MODIFICATION TO VERTE-STACK SPINAL SYSTEMMQP2006-09-26
2928031527399961K062073VERTE-STACK SPINAL SYSTEMMQP2006-08-14
2928031899777496K061938VERTE-STACK SPINAL SYSTEMMQP2006-08-09
2928031515227284K060719MODIFICATION TO VERTE-STACK SPINAL SYSTEMMQP2006-04-14
2928031283826972K052931MODIFICATION TO VERTE-STACK SPINAL SYSTEMMQP2005-11-16
2928031753971750K052261MODIFICATION TO: VERTE-STACK SPINAL SYSTEMMQP2005-10-07
2928031087333013K043566MODIFICATION TO VERTE-STACK SPINAL SYSTEMMQP2005-01-07
2928031721823790K041556MODIFICATION TO VERTE-STACK SPINAL SYSTEMMQP2004-07-01
2928031097409886K041452MODIFICATION TO VERTE-STACK SPINAL SYSTEMMQP2004-06-24
2928031840146304K041197MODIFICATION TO VERTE-STACK SPINAL SYSTEMMQP2004-08-09
2928031507485853K033926HOURGLASS VERTEBRAL BODY SPACERMQP2004-07-07
2928031372298362K031780VERTE-STACK SPINAL SYSTEMMQP2003-07-30
2928031958005442K030736VERTE-STACK SPINAL SYSTEM, EXTRA SMALL SIZESMQP2003-04-02
2928031253897185K030735MODIFIED VERTE-STACK SPINAL SYSTEMMQP2003-04-18
2928031652803393K030601VERTE-STACK SPINAL SYSTEMMQP2003-03-25
2928031593298364K021791VERTE-STACK SPINAL SYSTEMMQP2002-08-26
2928031056174418K012506MASTERGRAFT RESORBABLE CERAMIC GRANULESMQV2002-03-07
2928031723848715K010528TITANIUM CEMENT RESTRICTOR MATERIAL PEEKJDK2001-10-10
2928031091439111
2928031286923865
2928031473859133
2928031644538247
2928031758739127

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MAX232024-09-06
MQP172007-03-14
ODP52014-04-28
OVD42017-11-02
OVE42015-01-21
MQV32013-04-19
NQP22019-10-03
OLO12026-02-12
KCT12019-10-15
NKG12017-08-21
KWQ12014-07-09
NKB12009-08-14
LYC12009-01-09
NEK12002-07-02
JDK12001-10-10