FDA.reportPublic FDA data

GENESYS SPINE

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30084550343008455034GENESYS SPINE1N2026-01-011250 S Capital of TX Highway Building Three, Suite 600 Austin TX US 78746

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1216681685672290K252322SIros-X SystemOUR2025-10-22
1216681516367233K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemOVE2025-02-07
1216681689676209K233595Genesys Spine Sacroiliac Joint Fusion System with NavigationOLO2024-03-29
1216681238210566K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemOVE2023-12-13
1216682064073464K220096Genesys Spine 3DP Lumbar Interbody SystemMAX2022-03-09
1216681139067929K192678Genesys Spine Binary® Lumbar Plate SystemKWQ2019-10-24
1216681086769828K192076Binary® Anterior Cervical Plate SystemKWQ2019-08-29
1216681184208981K191748Genesys Spine Sacroiliac Joint Fusion SystemOUR2019-09-26
1216681376743582K191489Genesys Spine 3DP Cervical Interbody SystemOVE2020-01-08
1216681417753205K182987Genesys Spine 3DP Lumbar Interbody SystemMAX2019-12-12
1216681730247445K181295Genesys Spine AIS-C Cervical Stand-Alone SystemOVE2018-08-29
1216681641488045K180056Genesys Spine AIS-C Cervical Anchored Interbody SystemOVE2018-03-28
1216681385365839K173885Genesys Spine Binary Lumbar Plate SystemKWQ2018-04-03
1216681643720486K172469TiLock Modular Spinal SystemNKB2017-11-30
1216681499775604K171838TiLock2 Spinal SystemNKB2017-07-19
1216681854019854K171656Genesys Spine Apache Interbody Fusion SystemMAX2017-07-13
1216681099532046K161914Genesys Spine TiLock Cortical Spinal SystemNKB2016-08-09
1216681129579332K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemMAX2016-11-08
1216681721807315K161404Genesys Spine Apache® Lateral Lumbar Interbody Fusion SystemMAX2016-07-21
1216681379155532K153123Genesys Spine Apache Interbody Fusion SystemMAX2016-04-26
1216681310027528K152099Genesys Spine Apache® Anchored Cervical Interbody Fusion SystemOVE2016-07-28
1216681482130152K152039Genesys Spine TiLock2 Spinal SystemNKB2015-10-28
1216681181559455K150812Genesys Spine Apache Cervical Interbody Fusion SystemODP2015-09-03
1216681771502214K133911GENESYS SPINE ANTERIOR BUTTRESS PLATE SYSTEMKWQ2014-09-03
1216681865361803K133245GENESYS SPINE ANTERIOR CERVICAL PLATE II SYSTEMKWQ2014-10-08
1216681318892181K130913GENESYS SPINE APACHE LATERAL LUMBAR INTERBODY FUSION SYSTEMMAX2013-12-13
1216681589386036K130317GENESYS SPINE APACHE IBFD STAR CERVICAL SYSTEMODP2013-12-11
1216681307981216K111132GENESYS SPINE ANTERIOR CERVICAL PLATE SYSTEMKWQ2011-12-09
1216681635833653K103671GENESYS SPINE TILOCK SYSTEMNKB2011-07-21
1216681990677044K103034GENESYS SPINE INTERBODY FUSION SYSTEMMAX2010-12-10
1216681590263114K100757TILOCK PEDICLE SCREW SYSTEMNKB2010-07-01
1216681011466859
1216681072519903
1216681081386369
1216681136922182
1216681181578526
1216681249262327
1216681324529725
1216681346947617
1216681361084375
1216681374051088
1216681496657524
1216681756950324
1216681859003858
1216681865046351
1216681935504113

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MAX82022-03-09
OVE62025-02-07
KWQ62019-10-24
NKB62017-11-30
OUR22025-10-22
ODP22015-09-03
OLO12024-03-29

PMN#