FDA.report

SEASPINE ORTHOPEDICS CORPORATION

Matched from indexed company URL: Seaspine Orthopedics Corporation

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30121207723012120772SEASPINE ORTHOPEDICS CORPORATION1N2026-01-015770 Armada Dr Carlsbad CA US 92008

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1880911251383860K993503HAIDER-UCR SPINAL SYSTEMMNH2000-04-14
1880911706571265K983622BODYFORM THORACO-LUMBAR FIXATION SYSTEMKWQ1998-12-30
1880911786497567K250908Virata Spinal Fixation SystemNKB2025-06-18
1880911586689499K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System; Reef L Interbody System; Reef TO/TA System; Meridian Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; WaveForm A Interbody SystemMAX2024-06-20
1880911153614588K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; FORZA XP Expandable Spacer System; Shoreline ACS Interbody System; Shoreline RT Interbody System; Meridian Interbody System; WaveForm A Interbody SystemMAX2024-06-20
1880912056519882K240566Reef L Interbody System; WaveForm L Interbody SystemMAX2024-04-26
1880911429225876K233694Meridian Interbody System; WaveForm A Interbody SystemMAX2024-01-12
1880912069144955K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemOVE2023-11-28
1880911480882187K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System; Mariner Pedicle Screw Systems: Mariner Outrigger Revision System; Mariner MIS Pedicle Screw System; Mariner Deformity System; Mariner RDX SystemNKB2024-04-19
1880911731699835K231654NorthStar OCT SystemNKG2023-08-03
1880911559896753K222732WaveForm A Interbody SystemMAX2022-11-07
1880911512105072K222110Mariner RDX SystemNKB2022-09-07
1880911480674308K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemMAX2022-05-10
1880911915021541K220296Manta Ray TDF SpacerODP2023-02-03
1880911440119854K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemMAX2022-05-04
1880911727792353K213359SeaSpine WaveForm, C Interbody SystemOVE2021-12-09
1880911409591657K212904SeaSpine WaveForm C Interbody SystemOVE2021-12-14
1880911031837156K212692Mariner Pedicle Screw SystemNKB2021-09-21
1880911438748716K212540Explorer TO SystemMAX2021-09-10
1880912040292095K212139Admiral ACP SystemKWQ2021-09-01
1880911960188089K211903Shoreline Threaded TruProfile® PlateKWQ2021-08-30
1880911963543027K211606Mariner Deformity SystemNKB2021-06-23
1880912001366387K210583SeaSpine WaveForm™ A Interbody SystemMAX2021-06-02
1880911123848052K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu a•POD-L NanoMetalene, SeaSpine Vu e•POD System, SeaSpine Vu a•POD Prime NanoMetalene Intervertebral, SeaSpine Shoreline ACS - Anterior Cervical Standalone, SeaSpine Cervical Interbody RT System, SeaSpine Cambria System, SeaSpine Regatta Lateral System, SeaSpine Reef TO/TA System, SeaSpine Reef TH System, SeaSpine Meridian SystemMAX2021-07-07
1880911871491484K202064Admiral ACP SystemKWQ2020-08-26
1880911945688887K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemMAX2020-12-15
1880912010292593K201646Shoreline ACS (Anterior Cervical System)OVE2020-09-14
1880911142405692K201240Mariner Cap SystemOWI2020-08-05
1880911695557331K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu a•POD-L NanoMetalene; SeaSpine Vu e•POD System; and SeaSpine Reef TH System, SeaSpine Vu a•POD Prime NanoMetalene IBD; and SeaSpine Shoreline ACS, SeaSpine Cambria System; SeaSpine Regatta Lateral System; and SeaSpine Meridian System, Shoreline Cervical Interbody RT System; and SeaSpine Beachside SystemMAX2020-11-25
1880912045961311K201073Seaspine WaveForm C Interbody SystemOVE2020-09-18
1880911663803097K200885Meridian Anterior Plate System, Regatta Lateral Plate SystemKWQ2020-05-28
1880911324961667K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemMAX2020-06-10
1880911143885618K200381Daytona® Small Stature Spinal SystemNKB2020-02-28
1880911506218778K193636SeaSpine Reef TH SystemMAX2020-04-24
1880911501444436K193615NorthStar™ OCT Spinal SystemNKG2020-03-25
1880911993592391K193418SeaSpine Skipjack SystemMAX2020-03-13
1880911622023542K193224Daytona® Small Stature Growth Rod Conversion SetPGM2020-02-13
1880911976043417K192132SeaSpine Beachside SystemMAX2019-12-03
1880911362932195K191648Mariner MIS Pedicle Screw System; SeaSpine Navigation SystemNKB2019-07-19
1880911486508979K190655SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone SystemOVE2019-04-29
1880911589523217K183639Mariner Outrigger Revision SystemNKB2019-05-23
1880911033529211K183083Shoreline Cervical Interbody RT SystemODP2019-02-14
1880911161489845K181079SeaSpine Regatta Lateral SystemMAX2018-07-18
1880911419159558K180686SeaSpine Daytona Small Stature Spinal SystemNKB2018-05-14
1880912032693467K180176SeaSpine NewPort Spinal SystemNKB2018-02-20
1880911071423450K173882SeaSpine Mariner Pedicle Screw SystemNKB2018-02-06
1880911383248694K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu a•POD Prime Intervertebral Body Fusion DeviceOVD2018-04-13
1880911127043743K173521SeaSpine Cabo ACP (Anterior Cervical Plate) SystemKWQ2018-01-24
1880911739349054K173334SeaSpine Spinous Process SystemPEK2018-02-22
1880911617881098K173022SeaSpine Ventura NanoMetalene SystemMAX2017-10-26
1880911496837412K172517SeaSpine Navigation SystemOLO2018-05-11
1880911606264327K171046SeaSpine Cambria SystemODP2017-07-07
1880911765039991K170569SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemOVE2017-06-15
1880911838833518K163604SeaSpine® Daytona® Small Stature Spinal SystemNKB2017-03-09
1880911560201395K162715SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI NanoMetalene, Ventura NanoMetalene; SeaSpine Cambria NanoMetaleneMAX2016-10-28
1880911420778926K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceOVD2016-12-01
1880911103303194K161535SeaSpine® NewPort™ Spinal SystemNKB2016-09-08
1880911848184121K161081SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemOVE2016-09-14
1880911827814842K160902Mariner Pedicle Screw SystemNKB2016-05-26
1880911232950638K153786PROW FUSION-VMAX2016-07-11
1880911232950638K153786PROW FUSION-VMAX2016-07-11
1880911628970347K153665PROW FUSION-LMAX2016-09-15
1880911283898230K151654PROW FUSIONMAX2015-07-17
1880911672845396K150469Integra Laminoplasty SystemNQW2015-03-23
1880911967359590K142488SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, Cambria NanoMetalene , Vu aPOD-L NanoMetalene, Vu ePOD NanoMetaleneMAX2014-12-18
1880912014026954K133418INTEGRA EXPANDABLE INTERVEREBRAL BODY FUSION DEVICE (IBD) SYSTEMMAX2014-05-01
1880911144119464K133061ESPIN SYSTEMHRX2013-11-27
1880911312813474K132859INTEGRA FACET FIXATION SYSTEMMRW2013-11-18
1880911461064178K130830INTEGRA LAMINOPLASTY SYSTEMNQW2013-05-09
1880911933681788K130254PROW FUSIONMAX2013-10-16
1880911265002418K130057ESPINHRX2013-02-07
1880911886960170K122571MALIBU SPINAL SYSTEM WITH THE DAYTONA DEFORMITY SYSTEMNKB2012-12-12
1880911388821856K121924INTEGRA INTERSPINOUS PROCESS SYSTEMPEK2013-09-04
1880911417289562K121482INSTRUMENT SYSTEM FOR ENDOSCOPIC SPINAL SURGERYHRX2012-08-28
1880911021540520K121211VU APOD INTERVERTEBRAL BODY FUSION DEVICEOVD2012-06-27
1880911353693245K120829STAINLESS STEEL SPINAL SYSTEMNKB2012-05-30
1880911017488478K120553ESPINHRX2012-08-09
1880911748520618K120047CORAL SPINAL SYSTEMNKB2012-02-03
1880911908921864K112986LATERAL FUSION DEVICEMAX2012-05-01
1880911349205729K112359PROW FUSIONMAX2011-11-08
1880911285653322K111675VU C*POD INTERVERTEBRAL BODY FUSION DEVICEODP2011-08-02
1880911849680966K103297REDONDO-LMAX2011-01-27
1880911015482231K103228PARAMOUNT R IBF DEVICEMAX2011-01-05
1880911015482231K103228PARAMOUNT R IBF DEVICEMAX2011-01-05
1880911287066243K102323CERVICAL STANDALONE INTERVERTEBRAL BODY FUSION DEVICEOVE2010-12-16
1880911920321304K102026SEASPINE SPACER SYSTEMMAX2011-05-12
1880911637934518K101363VU CPOD INTERVERTEBRAL BODU FUSION DEVICEODP2010-12-16
1880911532043191K101310VU APOD INTERVERTEBRAL BODY FUSION DEVICEOVD2010-09-02
1880911823331470K100970STAINLESS STEEL SPINAL SYSTEMNKB2010-08-12
1880911934489188K092521ZUMA-COVE2010-04-13
1880911298318663K091266THEKEN CORAL SPINAL SYSTEMNKB2009-06-10
1880911631790005K083863THEKEN ATOLL OCT SPINAL SYSTEMMNI2009-03-27
1880911090269032K083089NEWPORT SPINAL SYSTEMNKB2009-01-13
1880911807936849K083073THEKEN ATOLL CERVICO-THORACIC SYSTEMMNI2009-03-13
1880911575065825K082926ZUMA, MODEL 55-XXXX/56-XXXXOVD2008-12-22
1880911844823257K082712THEKEN SPINE VU EPOD AND VU LPOD SYSTEMMAX2009-01-02
1880911413261282K082310HOLLYWOOD, PACIFICA, REDONDO, VENTURAMAX2008-11-10
1880911568302180K082309CAMBRIAODP2009-04-09
1880911102754812K081414MODIFICATION TO CORAL SPINAL SYSTEMNKB2008-06-17
1880911707901779K080822VU APOD INTERVERTABRAL BODY FUSION DEVICEOVD2008-07-02
1880911256013138K080790MODIFICATION TO THEKEN ATOLL CERVICO-THORACIC SYSTEMKWP2008-04-29
1880911572583876K080690MANTA RAY ANTERIOR CERVICAL PLATE SYSTEMKWQ2008-04-25
1880911050368925K080526SIERRA SYSTEMKWP2008-04-16
1880911991559380K072729SIERRAKWP2008-04-17
1880911138426093K072650IST ANTERIOR CERVICAL PLATE SYSTEMKWQ2007-11-28
1880911974554816K072605MALIBU SPINAL SYSTEMNKB2007-12-20
1880911960063305K072407BODYFORM THORACIC FIXATION SYSTEMKWQ2007-12-21
1880911451715436K071726ZUMAMQP2007-10-23
1880911167643349K071031VU E*POD VERTEBRAL BODY REPLACEMENTMQP2007-07-30
1880911571009607K070962CORAL PEDICLE SCREW SYSTEMNKB2007-08-22
1880911854127743K070638THEKEN ATOLL CERVICO-THORACIC SYSTEMKWP2007-05-30
1880911503298191K070381THEKEN VU MESH VBR SYSTEMMQP2007-04-25
1880911038837707K062934SIERRAMNI2006-11-16
1880911965470326K061342MALIBU SPINAL SYSTEMNKB2006-10-25
1880911838737651K052170SEASPINE VBR SYSTEMMQP2005-12-21
1880911617199171K051942MALIBU SPINAL SYSTEMKWP2005-07-27
1880911224743599K051663MALIBU SPINAL SYSTEMNKB2005-07-12
1880911564857660K050058THEKEN REVEAL VBR SYSTEMMQP2005-05-17
1880911564857660K050058THEKEN REVEAL VBR SYSTEMMQP2005-05-17
1880911023244575K043232UCR SPINAL SYSTEMNKB2004-12-21

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
MAX342024-06-20
NKB262025-06-18
KWQ132021-09-01
OVE102023-11-28
ODP62023-02-03
OVD62018-04-13
KWP62008-04-29
MQP62007-10-23
MNI52009-03-27
HRX42013-11-27
NKG22023-08-03
PEK22018-02-22
NQW22015-03-23
MNH22002-09-10
OWI12020-08-05
PGM12020-02-13
OLO12018-05-11
MRW12013-11-18

PMA

PMN

Applications

GUDID

NewPort™

2026-03-03

Seaspine Orthopedics Corporation

NewPort™

2026-03-03

Seaspine Orthopedics Corporation

NewPort™

2026-03-03

Seaspine Orthopedics Corporation

NewPort™

2026-03-03

Seaspine Orthopedics Corporation

NewPort™

2026-03-03

Seaspine Orthopedics Corporation