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MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30030065443003006544MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH1N2020-04-25WERFTSTR. 17 DEGGENDORF Bayern DE 94469

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
58191954472080P970015INTER FIX THREADED FUSION DEVICEMAX1999-05-14
58191596660047P000058INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICENEK2002-07-02
58191213819926K191066CD Horizon™ Astute™ Spinal SystemNQP2019-10-03
58192021215784K190165Capstone Control™ Spinal SystemMAX2019-05-06
58191989444160K182928CD Horizon™ Spinal SystemNQP2019-01-11
58191339363098K172328SOVEREIGN™ Spinal SystemOVD2017-11-02
58191817281054K172199ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System TitaniumMAX2017-09-19
58191850486800K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemMAX2017-09-26
58191863295055K171031CRESCENT™ Spinal SystemMAX2017-07-06
58191148579273K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMAX2015-06-11
58191017160543K133653ANATOMIC PEEK PTC CERVICAL FUSION SYSTEMODP2014-04-28
58191467469001K133650CAPSTONE SPINAL SYSTEMMAX2013-12-20
58191060642309K133216CRESCENT SPINAL SYSTEMMAX2013-11-22
58191486539884K133205CAPSTONE PTC SPINAL SYSTEM, CLYDESDALE PTC SPINAL SYSTEMMAX2014-03-13
58192052746260K132897CLYDESDALE SPINAL SYSTEMMAX2013-12-11
58191936499547K130335MASTERGRAFT STRIP; MASTERGRAFT ULTRAMATRIXMQV2013-04-19
58191597581382K123978CAPSTONE L SPINAL SYSTEMMAX2013-04-09
58191907016967K121982SOVEREIGN SPINAL SYSTEMOVD2012-07-26
58191527732545K121760CAPSTONE SPINAL SYSTEMMAX2012-08-29
58192015014199K120368CAPSTONE CONTROL SPINAL SYSTEMMAX2012-04-09
58191406234113K113528CLYDESDALE(R) SPINAL SYSTEMMAX2011-12-20
58191057877703K113252PEEK PREVAIL CERVICAL INTERBODY DEVICEOVE2012-01-17
58191061452244K112444ANATOMIC PEEK CERVICAL FUSION SYSTEMODP2011-11-15
58191887305584K112405CLYDESDALES SPINAL SYSTEMMAX2011-11-21
58191440749277K110562TELAMON PEEK SPINAL SYSTEMMAX2011-11-09
58191004936373K110063SOVEREIGN SPINAL SYSTEMOVD2011-10-04
58191536587307K100967PERIMETER C SPINAL SYSTEMODP2011-08-05
58191019915864K100175CLYDESDALE SPINAL SYSTEMMAX2010-06-02
58191959190979K094042PEEK PREVAIL CERVICAL INTERBODY DEVICEOVE2010-06-30
58191894606593K094025CRESCENT SPINAL SYSTEMMAX2010-04-26
58191494500234K091813INTREPID SPINAL SYSTEMOVD2009-11-17
58191608650094K090353PERIMETER INTERBODY FUSION DEVICEMAX2009-09-29
58191593673758K083026CLYDESDALE SPINAL SYSTEMMAX2008-12-29
58191715054451K082918MASTERGRAFT RESORBABLE CERAMIC GRANULESMQV2009-02-09
58192052341061K082917MASTERGRAFT RESORBABLE CERAMIC GRANULESLYC2009-01-09
58191522601494K082732MODIFICATION TO: CAPSTONE SPINAL SYSTEMMAX2008-10-16
58191637268244K080083INTREPID SPINAL SYSTEMMAX2008-04-10
58191852515669K073291CAPSTONE SPINAL SYSTEMMAX2008-04-24
58191986541277K073285PEEK PREVAIL CERVICAL INTERBODY DEVICEOVE2008-05-15
58191274413678K070173VERTE-STACK SPINAL SYSTEMMQP2007-03-14
58191522301392K062427VERTE-STACK SPINAL SYSTEMMQP2006-09-12
58192058530107K062133MODIFICATION TO VERTE-STACK SPINAL SYSTEMMQP2006-09-26
58191527399961K062073VERTE-STACK SPINAL SYSTEMMQP2006-08-14
58191899777496K061938VERTE-STACK SPINAL SYSTEMMQP2006-08-09
58191515227284K060719MODIFICATION TO VERTE-STACK SPINAL SYSTEMMQP2006-04-14
58191283826972K052931MODIFICATION TO VERTE-STACK SPINAL SYSTEMMQP2005-11-16
58191753971750K052261MODIFICATION TO: VERTE-STACK SPINAL SYSTEMMQP2005-10-07
58191087333013K043566MODIFICATION TO VERTE-STACK SPINAL SYSTEMMQP2005-01-07
58191721823790K041556MODIFICATION TO VERTE-STACK SPINAL SYSTEMMQP2004-07-01
58191097409886K041452MODIFICATION TO VERTE-STACK SPINAL SYSTEMMQP2004-06-24
58191840146304K041197MODIFICATION TO VERTE-STACK SPINAL SYSTEMMQP2004-08-09
58191074763636K040536MODIFICATION TO VERTE-STACK SPINAL SYSTEMMQP2004-05-05
58191507485853K033926HOURGLASS VERTEBRAL BODY SPACERMQP2004-07-07
58191303400160K031782GAPP GRAFT CONTIANMENT DEVICE ORTHOPEDICSKWQ2005-02-01
58191372298362K031780VERTE-STACK SPINAL SYSTEMMQP2003-07-30
58191958005442K030736VERTE-STACK SPINAL SYSTEM, EXTRA SMALL SIZESMQP2003-04-02
58191253897185K030735MODIFIED VERTE-STACK SPINAL SYSTEMMQP2003-04-18
58191652803393K030601VERTE-STACK SPINAL SYSTEMMQP2003-03-25
58191559035828K023570MODIFICATION TO VERTE-STACK SPINAL SYSTEMMQP2002-11-19
58191593298364K021791VERTE-STACK SPINAL SYSTEMMQP2002-08-26
58191664128901K020986MASTERGRAFT RESORBABLE CERAMICMQV2002-07-22
58191798396564K013663CEMENT RESTRICTORJDK2001-12-05
58191056174418K012506MASTERGRAFT RESORBABLE CERAMIC GRANULESMQV2002-03-07
58192068105198K010701MEDTRONIC SOFAMOR DANEK BIPHASIC CALCIUM PHOSPHATE (BCP) BONE VOID FILLERLYC2001-06-05
58191723848715K010528TITANIUM CEMENT RESTRICTOR MATERIAL PEEKJDK2001-10-10
58191091439111
58191644538247
58191758739127

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MAX232019-05-06
MQP202007-03-14
OVD42017-11-02
MQV42013-04-19
ODP32014-04-28
OVE32012-01-17
NQP22019-10-03
LYC22009-01-09
JDK22001-12-05
KWQ12005-02-01
NEK12002-07-02