FDA.reportPublic FDA data

HUNTINGTON

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10004322461000432246HUNTINGTON1N2020-04-2550 greene street, 4th floor New York NY US 10013

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
202861589530294K191134IB3D ALIFMAX2019-10-30
202861850391047K190376PASS LP Spinal SystemNKB2019-05-02
202861186075235K190092UNiD Patient specific 3D printed TLIF cageMAX2019-05-08
202862028215194K182240PASS LP Spinal SystemNKB2018-10-17
202861288045535K182158UNiD Patient-matched PLIF cageMAX2019-07-15
202861128837947K173782UNiD Patient Specific 3D printed cageMAX2018-04-25
202861404599029K173506LigaPASSOWI2018-04-03
202861677178577K172021LigaPASSOWI2017-08-30
202861757960737K170172UNiD Spine AnalyzerLLZ2017-05-24
202861355302408K163595IMPIX 3D Print CagesMAX2017-11-13
202861858946425K162786PASS LP Spinal SystemNKB2017-01-25
202861378810312K162194MEDICREA INTERNATIONAL Anterior Cervical Locking Plate SystemKWQ2016-12-08
202861282048945K161627PASS LP Spinal SystemNKB2016-07-29
202861939830443K161149PASS OCT Spinal SystemNKG2016-07-11
202861930916714K160756PASS OCT Spinal SystemNKG2016-04-26
202861069525052K160698LigaPASSOWI2016-09-02
202861136350397K160640PASS XS Spinal SystemNKB2016-09-23
202862012240532K153413PASS LP Spinal SystemNKB2016-04-22
202861609604123K153169PASS OCT Patient Specific RodsNKG2016-01-29
202861145308622K150918PASS OCT Spinal SystemNKG2015-10-16
202861564511995K150049PASS LP Spinal SystemMNI2015-02-10
202861906598912K142798PASS LP Spinal SystemMNH2015-03-25
202861982792849K141398PASS LP SPINAL SYSTEMNKB2015-01-09
202861099784005K141187IMPIX ALIF S/AOVD2015-01-15
202861480982777K140738PASS LP SPINAL SYSTEMMNI2014-11-04
202861793047368K133906C-JAWS CERVICAL COMPRESSIVE STAPLEPHQ2014-07-24
202861656637733K132575PASS LP SPINAL SYSTEMOSH2013-10-03
202861930865216K132574PASS LP SPINAL SYSTEMOSH2013-11-08
202861154179084K132395LIGAPASSOWI2013-12-06
202861323486681K131157RANFAC BONE MARROW ASPIRATION NEEDLEKNW2013-10-22
202861786790469K123138PASS LP SPINAL SYSTEMOSH2013-02-05
202861606273632K121979PASS OCT SPINAL SYSTEMKWP2013-03-21
202861261162046K121323MEDICREA INTERNATIONAL ANTERIOR LUMBAR PLATEKWQ2012-07-18
202861556389067K112736PASS LP SPINALJDQ2012-02-01
202861715071849K112493PASS LP SPINAL SYSTEMMNI2011-11-21
202861081116329K110497PASS LP SPINAL SYSTEMMNH2011-09-26
202861311747551K102406PASS ANTERIOR SPINAL SYSTEMKWQ2011-08-23
202861465227529K100544IMPIX LUMBAR INTERBODY DEVICEMAX2010-07-22
202861993333490K100484IMPIX MANTA CERVICAL INTERBODY DEVICEODP2010-03-16
202861976049046K100297PASS LP SPINAL SYSTEMMNI2010-03-04
202861139874013K083810PASS LP SPINAL SYSTEMMNI2009-07-31
202862020942386K083798IMPIX ALIF LUMBAR IBF, IMPIX ALIF-D LUMBAR IBF, IMPIX TLIF LUMBAR IBFMAX2010-05-19
202861640628358K083308PASS LP SPINAL SYSTEMMNI2008-12-10
202861537097730K082577PASS LP SPINAL SYSTEMMNH2008-10-03
202861284452980K082069PASS 2 SPINAL SYSTEMMNI2008-10-03
202861730433614K080099PASS SPINAL SYSTEMMNI2008-04-09
202861911958250K072226IMPIX SPACERMAX2007-12-10
202861892545981K072040C-JAWS CERVICAL COMPRESSIVE MINI FRAMEKWQ2007-08-03
202861890266128K070530MODIFICATION TO PASSMED SPINAL SYSTEMMNH2007-10-18
202861302508327K070276MODIFICATION TO PASSMED SPINAL SYSTEMMNI2007-09-21
202861526142400K062181C-JAWS CERVICAL COMPRESSIVE MINI FRAMEKWP2007-01-16
202861521241448K062136PASS 2 SPINAL SYSTEMMNI2006-10-06
202861602229820K050490OSMOSYS CALCIUM PHOSPHATE CERAMIC BONE FILLERMQV2005-04-11
202861844892172K032094PASSMED SPINAL SYSTEMKWP2003-11-14
202861060335529
202861077621301
202861090371132
202861151944094
202861237492547
202861295544735
202861327558170
202861328214984
202861334967135
202861391407126
202861560610412
202861561503412
202861608415556
202861612759716
202861630114417
202861773304302
202861855811977
202861876268381
202861886226639
202861914957822
202861924796985
202861962434104
202861975588587
202861982213636

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MNI102015-02-10
MAX82019-10-30
NKB72019-05-02
OWI42018-04-03
KWQ42016-12-08
NKG42016-07-11
MNH42015-03-25
OSH32013-11-08
KWP32013-03-21
LLZ12017-05-24
OVD12015-01-15
PHQ12014-07-24
KNW12013-10-22
JDQ12012-02-01
ODP12010-03-16
MQV12005-04-11

PMN#

SANA-LUBE

1985-11-13

HUNTINGTON LABORATORIES, INC.

Applications#