FDA.reportPublic FDA data

SPINEART SA

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30077282663007728266SPINEART SA1N2026-01-01Chemin du Pre-Fleuri 3 Plan-les-Ouates Geneve CH 1228

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1015161940327825K254158SPINEART Navigation Instrument SystemOLO2026-04-09
1015161609280784K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemNKB2026-05-01
1015161988271906K242933SPINEART Navigation Instrument SystemOLO2025-06-18
1015162025214253K242890SPINEART Navigation Instrument SystemOLO2025-03-07
1015161946579215K242589Scarlet® AL-TMAX2024-10-23
1015161437232738K241644SPINEART Navigation Instrument SystemOLO2024-08-07
1015161682105866K241321Juliet® Ti LL Lumbar Interbody DeviceOVD2024-07-18
1015161321565260K240699SCARLET® AC-TiOVE2024-05-10
1015161169817055K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemNKB2023-10-25
1015161464332269K230774PERLA® TL System; TEKTONA® HV US Bone CementPML2023-06-23
1015161845846452K230583Tryptik TiODP2023-03-22
1015161984022365K213470PERLA® TL Posterior Osteosynthesis SystemNKB2022-01-21
1015161421122227K210472SPINEART Navigation Instrument SystemOLO2021-03-19
1015161472782652K210286Cure 2.0 Anterior Cervical Plate (ACP) SystemKWQ2021-03-18
1015161304324829K203506PERLA® TL posterior osteosynthesis systemNKB2021-01-15
1015161642661918K203222PERLA TL Posterior Osteosynthesis SystemNKB2020-12-17
1015161513447438K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical Intervertebral Body Fusion SystemODP2020-09-11
1015161525120122K201136Cure™ Lumbar Plate SystemKWQ2020-05-12
1015161695655557K200571PERLA® Posterior Occipito-Cervico-Thoracic Fixation SystemNKG2020-05-01
1015161013450679K200312Tryptik TiODP2020-04-06
1015161001378293K193396PERLA® TL posterior osteosynthesis systemNKB2020-02-05
1015161564169452K192993SCARLET AL-TOVD2020-01-22
1015161119113105K190877Juliet® Ti LL Lumbar Interbody DeviceOVD2019-05-29
1015161372925146K190322SCARLET® AC-T Secured Anterior Cervical CageODP2019-03-04
1015161584924998K190071Perla® Posterior Cervico-Thoracic Fixation SystemNKG2019-02-25
1015161414776448K183630SPINEART Navigation Instrument SystemOLO2019-06-10
1015161203331741K181818Scarlet AL-TOVD2018-10-09
1015161043709887K181543Cure™ OPEL-C Plate SystemKWQ2018-08-31
1015161986344638K181203Juliet TiMAX2018-06-28
1015161678300418K180090Cure™ Lumbar Plate SystemKWQ2018-04-23
1015161323202594K173702Juliet Ti LLMAX2018-01-03
1015161176655993K172101ROMEO® 2 Posterior Osteosynthesis SystemNKB2017-09-26
1015161079078178K172065SCARLET AC-TODP2017-09-29
1015161018662881K171797TRYPTIK2 C-Plate Anterior Cervical Plate SystemKWQ2018-02-26
1015161234648798K171538Cure™ Lumbar Plate SystemKWQ2017-06-16
1015162022449510K170395Talos® Lumbar (HA) PEEK IBF DevicesMAX2017-06-02
1015161308390167K161888JULIET® LL Lateral Lumbar CageMAX2016-09-12
1015161282398515K160604Cure™ Anterior Cervical Plate (ACP) SystemKWQ2016-07-01
1015161277765422K153621Juliet® TiMAX2016-07-15
1015161567149570K153386Perla Posterior Cervico-Thoracic Fixation systemNKG2016-01-25
1015161029612242K153042TRYPTIK2C-plate Anterior Cervical Plate SystemKWQ2016-03-28
1015161064250179K151695Romeo posterior osteosynthesis systemMNH2015-09-10
1015161946523866K151104OTELO LLGAD2016-01-06
1015161902212735K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion Devices, Talos -C(HA) Cervical Intervertebral Body Fusion DevicesODP2015-10-14
1015161058600185K143214SCARLET® AC-T Secured Anterior Cervical CageOVE2015-02-23
1015162063934512K142345Talos-C(HA) Cervical Intervertebral Body Fusion DevicesODP2015-02-22
1015161560673526K142277JULIET POMAX2014-10-14
1015161000688396K141835ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM PREBENT CROSS-CONNECTORS; PREBENT RODSMNI2014-09-10
1015161873689679K141508ROMEO 2 PAD POSTERIOR AXIAL DEVICEPEK2014-08-21
1015161269313561K141314SCARLET AC-T SECURED ANTERIOR CERVICAL CAGE AND ASSOCIATED INSTRUMENTATIONOVE2014-09-29
1015161680843986K141135JULIET LLMAX2014-12-01
1015161273922988K140948ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEMMNH2014-05-20
1015161069547191K140474JULIET OLMAX2014-04-18
1015161271332203K133557JULIET LL LATERAL LUMBAR CAGEMAX2014-02-03
1015161388350089K130267ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEMMNH2013-05-31
1015161818741007K122850TALOS-C CERVICAL INTERVERTEBRAL BODY FUSION DEVICESODP2013-03-28
1015161099537080K122366TRYPTIK CC ANTERIOR INTERSOMATIC CERVICAL CAGEODP2012-10-04
1015162058691286K112108ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEMMNI2011-08-19
1015161829517480K111127ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEMMNI2011-08-11
1015162001341187K101720JULIET OLMAX2010-07-16
1015161929217189K101678ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEMMNH2010-07-28
1015161450026049K093936ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEMMNI2010-03-11
1015161142861659K093170ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEMMNI2009-11-04
1015161011604971K091873TRYPTIK CA ANTERIOR INTERSOMATIC CERVICAL CAGE, MODELS MOS-CA 12 05-S, MOS-CA 12 O6-SODP2009-09-18
1015161128383042K090707TALOS INTERVERTEBRAL BODY FUSION DEVICEMAX2009-07-15
1015161493153197K081888DYNAMIK INTERVERTEBRAL BODY FUSION DEVICEMAX2009-02-06
1015161975520684K081165ELLIPSE LUMBAR POSTERIOR OSTEOSYNTHESIS SYSTEMMNH2008-12-17
1015161685872668K062260OSTEOBOOST-BMAFMF2006-10-26
1015161975731753K041616BGRAN SYNTHETIC OSTEOCONDUCTIVE SCAFFOIDMQV2004-08-25
1015161009294832
1015161026047705
1015161027681143
1015161048595010
1015161048947979
1015161069776162
1015161076458223
1015161094806934
1015161155181290
1015161160320385
1015161308504722
1015161312138718
1015161329822189
1015161366086711
1015161370055075
1015161377386308
1015161379485701
1015161450784752
1015161489807620
1015161557127216
1015161558512678
1015161600777918
1015161634391081
1015161649173655
1015161650274717
1015161650959693
1015161713697273
1015161724905685
1015161758912546
1015161798144187
1015161825976399
1015161917692944
1015162058553463

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MAX132024-10-23
ODP102023-03-22
KWQ82021-03-18
NKB72026-05-01
OLO62026-04-09
MNH52015-09-10
MNI52014-09-10
OVD42024-07-18
OVE32024-05-10
NKG32020-05-01
PML12023-06-23
GAD12016-01-06
PEK12014-08-21
FMF12006-10-26
MQV12004-08-25

PMN#

GUDID#

200 records. Showing 1-40. Next