FDA.report

SPINAL ELEMENTS, INC.

Matched from indexed company URL: Spinal Elements, Inc.

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30048933323004893332SPINAL ELEMENTS, INC.1N2026-01-013115 Melrose Dr Suite 200 CARLSBAD CA US 92010
30123411293012341129Spinal Elements1N2020-04-2547354 Fremont Blvd. Fremont CA US 94538

GUDID Contact Samples

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDIDProductPhoneEmail
00840606174800Primus - K-WIRE HOLDER7606070121customerservice@spinalelements.com
00840606187138Primus - Primus MIS SFS Core Instruments Tray7606070121customerservice@spinalelements.com
00840606187145Primus - Primus MIS SFS Core Instruments Tray7606070121customerservice@spinalelements.com
00840606187152Primus - Primus MIS SFS Core Instruments Tray7606070121customerservice@spinalelements.com

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2130251463932230K253559Ventana™ A Anterior Lumbar Interbody SystemOVD2026-02-25
2130251991464614K243916Primus Spinal Fixation SystemNKB2025-02-21
2130251740086325K242527The Karma® Fixation SystemMRW2025-05-21
2130251780048640K234150Lucent® XPMAX2024-03-27
2130251249157707K231593Sapphire X3 Anterior Cervical Plate SystemKWQ2023-08-02
2130251202880380K231252Ventana™ L Spinal SystemMAX2023-06-30
2130251916800255K222833Ventana™ C Spinal SystemODP2023-05-19
2130251823075011K222516Mercury® II Spinal SystemNKB2022-12-01
2130251636259945K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System, Ceres-C Spinal System, Omega XP Spinal SystemMAX2021-06-30
2130251186295132K203254Lucent 3D Spinal SystemMAX2021-03-26
2130251655458294K202298Lucent XP, Lucent XP CurvedMAX2020-12-22
2130251397192186K201029Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal SystemKWQ2020-06-17
2130251577758125K193172Luna XD Ti Interbody Fusion SystemMAX2020-07-02
2130251609368838K191576Mercury® Spinal System, Overwatch® Spinal SystemNKB2019-09-16
2130251924328805K190881Spinal Elements Navigated InstrumentsOLO2019-12-19
2130251344149169K190289Karma® Fixation SystemOWI2019-04-03
2130251480892308K183560Luna 3D GEN2 Interbody Fusion SystemMAX2019-05-23
2130251353114314K182584Lucent® XPMAX2018-12-10
2130251644420524K181837Spinal Elements Ti-Bond coated devicesMAX2018-11-02
2130252023605899K180728Spinal Elements Cerclage SystemOWI2018-09-06
2130251659038171K172967Mercury® Spinal SystemNKB2018-04-10
2130251339877105K170235Lucent®MAX2017-11-29
2130251456804391K162431Luna 3D Interbody Fusion SystemMAX2016-11-17
2130251678494615K161842Overwatch Spine SystemNKB2016-10-13
2130251592735599K160924Amendia Interbody Fusion DevicesMAX2016-11-08
2130251193975334K160465Spinal Elements' Spinous Process Plate SystemPEK2016-07-28
2130251031258693K160291Optimus ALIF SystemOVD2016-02-18
2130251430623016K153352Vertu® & Vertu® Ti-Bond and Crystal® & Crystal® Ti-Bond Cervical Interbody SystemOVE2016-08-01
2130251973581230K153152Syzygy Stabilization SystemNKB2016-04-27
2130251998342722K152972Amendia Stand-Alone Cervical SystemOVE2016-01-14
2130251006425946K152920Savannah-T® Pedicle Screw SystemNKB2016-07-08
2130251633453345K152460Rectangular Corpectomy CageMQP2015-12-22
2130251052893014K152455Amendia Cervical Plate SystemKWQ2015-10-15
2130252020184750K152011Lucent Intervertebral Body Fusion DeviceMAX2016-06-09
2130251089850233K151705Lotus Posterior Cervical/Thoracic Spinal SystemNKG2015-09-03
2130251973604359K151322Amendia Interbody Fusion DevicesMAX2015-09-10
2130251712741477K151310Amendia Interbody Fusion DevicesMAX2016-01-06
2130251043484304K151215Mercury Spinal SystemNKB2015-06-03
2130251665143579K150395Omega LIF SystemMAX2015-08-10
2130251897204333K150061Lucent; Lucent Ti-Bond SystemsMAX2015-05-19
2130251763849520K141372MERCURY SPINAL SYSTEMNKB2014-08-22
2130251339104424K133218Crystal ®; Mosaic ®; Vertu ®OVE2014-12-10
2130251327437157K132925SAVANNAH-T, REDUCTION, SAVANNAH-T, HIGH-TOP, SAVANNAH-T, MONOAXIAL MID-TOP, SAVANNAH-T, LOW-TOP, SAVANNAH-LINKNKB2014-02-11
2130251734370337K132596PROPOSED OPTIMUSOVD2014-04-11
2130251572432837K132122KESTREL POSTERIOR CERVICAL SPINE SYSTEMKWP2014-01-22
2130251153018175K131427LOTUSKWP2013-10-24
2130251767405474K122967LUCENTMAX2013-02-21
2130251307060166K122771SPINAL ELEMENTS CERVICAL INTERVERTEBRAL BODY FUSION SYSTEMOVE2013-01-10
2130251736310036K122085STINGRAY CERVICAL CAGEODP2012-10-17
2130251191706072K120467SPINAL ELEMENTS POSTERIOR CERVICAL/THORACIC SPINAL SYSTEMNKB2012-07-30
2130251119529514K120177SPINAL ELEMENTS CERCLAGE SYSTEMJDQ2012-07-03
1947811404289978K113533NEURO CHECK DEVICE WITH IO-FLEX WIREHAE2012-04-11
2130251404289978K113533NEURO CHECK DEVICE WITH IO-FLEX WIREHAE2012-04-11
2130251717150139K113361SECURIS SPINAL FIXATIONNKB2012-04-03
2130251336983819K113011SPARTAN S3 FACET SYSTEMMRW2011-12-06
2130251151964643K111774PATHWAY MODEL 07XXXXMAX2011-07-20
2130251899261431K111099ISSYS LP SPINAL FIXATION SYSTEMNKB2011-05-05
1947811875809828K110696NEURO CHECK DEVICE WITH IO-FLEX WIREETN2011-07-07
2130251875809828K110696NEURO CHECK DEVICE WITH IO-FLEX WIREETN2011-07-07
2130251519569008K110632LUCENT OR LUCENT MAGNUMMAX2012-05-23
2130251044203835K110047VERTICOR K-WIRE SYSTEMHTY2011-02-28
2130251350371446K102995TALON SPINAL SYSTEMMNI2011-02-02
1947811149538551K102594IO-FLEX CATHETERBSO2011-01-19
2130251149538551K102594IO-FLEX CATHETERBSO2011-01-19
2130251715201585K102322STINGRAY CERVICAL CAGE; SHARK IMPLANT (PLIF); BULL SHARK IMPLANT(PLIF); TIGER IMPLANT (TLIF); GREAT WHITE IMPLANTS(ALIF)MAX2011-01-07
2130251869998926K101848SAPPHIRE ANTERIOR CERVICAL PLATE SYSTEMKWQ2010-10-14
2130251979113726K101151REGENT ANTERIOR CERVICAL PLATEKWQ2010-05-19
1947811094179653K100958MODIFICATION TO: MICROBLADE SHAVER AND ACCESSORIESHAE2010-07-23
2130251094179653K100958MODIFICATION TO: MICROBLADE SHAVER AND ACCESSORIESHAE2010-07-23
2130251587578503K100265DIAMOND ANTERIOR CERVICAL PLATE SYSTEMKWQ2010-05-13
2130251932677025K092568SPARTAN S3 FACET SYSTEMMRW2009-11-17
2130251391514091K092531SPINE360 ANTERIOR CERVICAL PLATE SYSTEMKWQ2010-02-04
2130251129939723K091587MERCURY SPINAL SYSTEMNKB2009-07-01
2130251139970298K091426CERVICORE CORPECTOMY CAGEMQP2009-12-23
2130251033580766K091134CUSTOM SPINE REGENT ANTERIOR CERVICAL PLATEKWQ2009-08-17
2130251251226445K083475LUCENT MAGNUMOVD2009-02-13
2130251953701438K083230MERCURY SPINAL SYSTEMNKB2008-12-03
2130251687810589K083167PHENIX CERVICAL INTERBODY DEVICEODP2009-01-13
2130251040730167K082992AXXION LIGHT GUIDEFST2009-02-18
2130251353495442K082353MERCURY SPINAL SYSTEMNKB2009-01-22
2130251638877130K081968MODIFICATION TO LUCENTMAX2008-08-05
2130251257417946K081770BLACK WIDOW ANTERIOR BUTTRESS PLATEKWQ2009-04-02
2130251058456088K081711LUCENT MAGNUM+OVD2008-09-11
2130251782902858K081614ZEUS SMALL CERVICAL CAGE AND LARGE, EXTRA LARGE, CURVED AND STRAIGHT LUMBAR CAGESODP2008-09-05
2130252045437957K081418SPINAL ELEMENTS BUTTRESS PLATE SYSTEMKWQ2008-07-14
2130251785454923K081240TIGER DISCECTOMY DEVICEHRX2009-02-27
2130251961766847K080281PATHWAYMAX2008-05-01
2130251701746048K080058TURBO PRIME IBD SYSTEMMAX2008-04-16
2130252031414961K073351CRYSTALODP2008-01-24
2130251207446565K073348LUCENT MAGNUMMAX2007-12-26
2130251837962814K072866ISSYS LP SPINAL FIXATION SYSTEMKWP2007-12-13
2130251895642560K072116SAVANNAH LUMBAR PERCUTANEOUS STABILIZATION SYSTEMNKB2008-03-20
2130251105844803K072029PHENIX VERTEBRAL BODY REPLACEMENTMQP2007-10-15
2130252070456062K071914MERCURY SPINAL SYSTEMNKB2007-10-12
2130251581971471K071833MOSAIC DEVICESOVE2007-10-23
2130251215900644K071824ACME TALON PEDICLE SCREWMNI2007-09-04
2130251921183306K071724LUCENTMAX2007-11-09
2130251174470003K070281ISSYS LP SPINAL FIXATION SYSTEMNKB2007-06-11
2130251991734225K060491QUANTUM ANTERIOR CERVICAL PLATE SYSTEMKWQ2006-03-13
2130251215197004K050377NBD HEAD SCREWHAW2005-04-07
2130251784163033K043522ISSYS PEDICLE SCREW SYSTEMKWP2005-01-14
2130251249319248
2130251385984672
2130251609218532
2130251834541546

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
MAX262024-03-27
NKB192025-02-21
KWQ112023-08-02
OVD62026-02-25
ODP52023-05-19
OVE52016-08-01
KWP42014-01-22
HAE42012-04-11
MRW32025-05-21
MQP32015-12-22
OWI22019-04-03
ETN22011-07-07
MNI22011-02-02
BSO22011-01-19
OLO12019-12-19
PEK12016-07-28
NKG12015-09-03
JDQ12012-07-03
HTY12011-02-28
HRX12009-02-27
FST12009-02-18
HAW12005-04-07

PMN

LOTUS

2013-10-24

SPINAL ELEMENTS, INC.

LUCENT

2013-02-21

SPINAL ELEMENTS, INC.

46 records. Showing 1-40. Next

GUDID

200 records. Showing 1-40. Next