FDA.reportPublic FDA data

ZAVATION

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30085837933008583793ZAVATION1N2026-01-013670 Flowood Dr Flowood MS US 39232

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2100051551458093K243908Tiger 2 SystemNKB2025-02-03
2100051949156932K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF SystemMAX2024-04-10
2100051714236833K231811Zavation Connector SystemNKB2023-08-22
2100051199097056K231743
2100052060307269K230880CoreLink Navigation InstrumentsOLO2023-05-02
2100051710924991K230731Zavation ALIF SystemOVD2023-06-14
2100051074210768K230329F3D Interbody SystemODP2023-06-06
2100051522020828K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemOUR2023-03-21
2100051651804003K222614Zavation Spinal SystemNKB2022-12-05
2100051021846131K221776NextGen Pedicle Screw SystemNKB2022-08-09
2100051663054322K221726Uni-FuZe-C Bone StripMQV2023-01-18
2100051549922058K221049Zavation VariSync Plate System and VariSync Spacer SystemOVE2022-08-12
2100051902195569K220973CoreLink Navigation InstrumentsOLO2022-06-01
2100051006248307K214059CoreLink Navigation InstrumentsOLO2022-01-19
2100051039032172K212825CoreLink Navigation InstrumentsOLO2021-10-13
2100051161599350K211993Z-LINKPC SystemNKG2021-08-11
2100051954438061K211417F3D-C2 Cervical Stand-Alone SystemOVE2022-02-04
2100051446338798K211306LABYRINTHMAX2021-06-24
2100052028971993K211113Zavation Spinal SystemNKB2021-07-12
2100051585437648K210539CoreLink Midline Fixation SystemNKB2021-04-15
2100052045115528K202637F3D Corpectomy SystemMQP2020-12-23
2100051685964032K202624Z-Span Plate SystemKWQ2020-11-04
2100051483923699K202305Zavation IBF SystemMAX2020-10-13
2100051867977005K201781Uni-FuZe-P Bone PuttyMQV2020-12-28
2100051744445327K200863Tiger® Occipital-Cervical-Thoracic Spinal Fixation SystemNKG2020-04-28
2100051172100215K200087F3D Cervical Stand-Alone Interbody Fusion SystemOVE2020-06-15
2100051295171410K200084Zavation IBF SystemMAX2020-10-19
2100051699848106K191423Normandy VBR SystemPLR2019-08-06
2100052062277563K191354Ti3Z Cervical Interbody SystemODP2019-09-09
2100051410085744K191339Zavation eZspand Interbody SystemMAX2019-08-19
2100051289107015K190361Zavation Spinal SystemNKB2019-03-18
2100051651245505K190317Zavation Spinal SystemNKB2019-04-11
2100051030783867K190016Lateral Plate SystemKWQ2019-06-12
2100051892152645K183239CoreLink F3D™ Lateral SystemMAX2018-12-19
2100051772381616K182731Corelink Navigation InstrumentsOLO2019-12-13
2100051369239256K181246Zavation IBF SystemMAX2018-07-10
2100051369125398K181244Zavation Cervical Plate SystemKWQ2018-07-10
2100051419703530K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemOVD2018-08-10
2100051279898417K180673Normandy VBR SystemPLR2018-07-13
2100051431149638K180556Corelink Foundation 3D Anterior Lumbar SystemMAX2018-07-27
2100051997418306K180076Ti 3Z Interbody SystemMAX2018-07-27
2100052009543808K173752SI Screw SystemOUR2018-03-16
2100051808162638K173306EZ PlateKWQ2018-01-22
2100051353840737K171519FLXfit™MAX2017-09-15
2100051085773448K163104Terrace™ Anterior Cervical Plate SystemKWQ2017-06-21
2100051979686130K162824Z-Span Plate SystemKWQ2017-02-17
2100051118440209K162575Z-LINKPC SystemNKG2017-03-03
2100051448180611K162496Foundation 3D InterbodyODP2017-05-04
2100051817041394K16245313G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex)NDN2016-11-01
2100052022994181K162206Zavation IBFMAX2017-04-04
2100051200020450K161016Z-Clamp ISP SystemPEK2016-10-19
2100051738259569K160362Z-Span Plate SystemKWQ2016-03-22
2100051314539730K153404Zavation Spinal SystemMNH2016-04-21
2100051652440608K152237The Entasis Dual-Lead Sacroiliac ImplantOUR2016-02-04
2100051895385274K150847Foundation Interbody DevicesODP2015-08-13
2100051162874439K150322InterV Kyphoplasty Catheter (Balloon Length: 10,15 and 20mm) InterV Kyphoplasty Catheter (Mini) (Balloon Length: 10, 15 and 20mm)NDN2015-03-06
2100051483566507K143228Ancora LLC Interbody Fusion DeviceOVD2015-02-26
2100051493368708K142392Zavation Posterior LEIFMAX2015-04-29
2100051130749146K142271Zavation Z-Link LumbarOVD2014-12-19
2100051523520636K141419ZVPLASTYNDN2014-09-12
2100051909782345K141005Z-LINK CERVICALOVE2014-08-07
2100051449557430K140844BIOSPHERE BIOACTIVE BONE GRAFT PUTTY, 2.5CC, 5CC, 10CCMQV2014-07-16
2100051716039129K133813FLXFIT INTERVERTEBRAL BODY FUSION DEVICEMAX2014-07-15
2100051651097645K133369TIGER SPINE SYSTEMNKB2014-01-14
2100051980759098K132994ANODYNE ANTERIOR CERVICAL PLATE SYSTEMKWQ2013-12-05
2100051646265397K132620INTER V KYPHOPLASTY CATHETER (BALLOON LENGTH: 0 MM), INTERV KYPHOPLASTY CATHETER (BALLOON LENGHT: 15 MM), INTERV KYPHOPLNDN2014-04-16
2100051408342402K132504TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEMKWP2013-11-25
2100051972457563K132126SPECTRUM SPINE FENESTRATED FACET SCREW SYSTEMMRW2013-10-28
2100051315492661K131250TIGER SPINE SYSTEMNKB2013-09-10
2100051553991404K130030ZAVATION CERVICAL PLATE SYSTEMKWQ2013-04-25
2100051029519755K121791ZOU ANTERIOR LUMBAR PLATE SYSTEMKWQ2012-11-19
2100051702440798K121728TIGER SPINE SYSTEMNKB2012-10-05
2100052010418080K121514ANODYNE ANTERIOR CERVICAL PLATE SYSTEMKWQ2012-12-14
2100051206548682K120696TIGER SPINE SYSTEMMNI2012-04-02
2100051676006030K120576ZAVATION IBF SYSTEMMAX2012-03-28
2100051608601343K113058TIGER SPINE SYSTEMNKB2012-03-29
2100051610859391K112700FRONTIER SADL INTERBODY FUSION DEVICEOVD2012-11-01
2100051572772510K112664ZAVATION IBF SYSTEMSODP2011-12-23
2100051954915722K112533ZAVATION CERVICAL PLATE SYSTEMKWQ2011-12-08
2100052005618723K112484ZAVATION SPINAL SYSTEMMNI2011-11-22
2100051582409117K110321TIGER SPINE SYSTEMMNH2011-05-25
2100051871894155K102937OSTEOPHIL BETA-TCPMQV2010-12-27
2100051748870245K073440FOUNDATION CAGEMAX2008-04-24
2100051462082856K052812OSSIMEND (TM) BONE GRAFT MATERIALMQV2006-01-25
2100051118339696
2100051130259159
2100051241214389
2100051277725811
2100051354463199
2100051372596096
2100051376254603
2100051377720166
2100051467406314
2100051485046951
2100051515013112
2100051523076702
2100051599957957
2100051604148533
2100051708389648
2100051767126142
2100051784848795
2100051820001502
2100051831949912
2100051858963963
2100051882214106
2100051889521748
2100051891596595
2100051919546897
2100051957089602
2100051964449471
2100051974502447
2100052035752439

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MAX152024-04-10
NKB122025-02-03
KWQ122020-11-04
OVD52023-06-14
ODP52023-06-06
OLO52023-05-02
MQV52023-01-18
OVE42022-08-12
NDN42016-11-01
OUR32023-03-21
NKG32021-08-11
PLR22019-08-06
MNH22016-04-21
MNI22012-04-02
MQP12020-12-23
PEK12016-10-19
KWP12013-11-25
MRW12013-10-28