FDA.reportPublic FDA data

STRYKER SPINE

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96175443003112432STRYKER SPINE1N2026-01-01ZONE INDUSTRIELLE DE MARTICOT CESTAS Nouvelle-Aquitaine FR 33610
30040249553004024955STRYKER SPINE1N2026-01-012 PEARL COURT ALLENDALE NJ US 07401
30040249553004024955STRYKER SPINE1Y2020-04-252 PEARL COURT ALLENDALE NJ US 07401
30055250323005525032STRYKER SPINE SARL1N2020-04-25LE CRET DU LOCLE 10A LA CHAUX DE FONDS Neuchatel CH 2300

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
37871138565074P950019RAY THREADED FUSION CAGE (TFC)(TM) WITH INSTRUMENTATIONMAX1996-10-29
37871736135457P050044VITAGEL RT3 SUTGICAL HEMOSTATPMX2006-06-16
37871563662308K994347CENTAUR SPINAL SYSTEMKWQ2000-03-15
3391661429214573K994337VITOSS SCAFFOLD SYNTHETIC CANCELLOUS BONE VOID FILLERMQV2000-12-14
37871955838499K994337VITOSS SCAFFOLD SYNTHETIC CANCELLOUS BONE VOID FILLERMQV2000-12-14
37871296400107K993402OPUS SPINAL SYSTEMMNI1999-12-20
37871056596225K993181HOWMEDICA OSTEONICS ACCP SYSTEM CORTICAL SCREWSKWQ1999-10-22
37871792762601K992792XIA SPINAL SYSTEM C-C ADAPTORKWQ1999-11-16
37871661567023K992784NEXT GENERATION RODDING SYSTEMKWQ1999-10-27
37872055270707K992344OSTEONICS ACCP SYSTEM LINE EXTENSIONKWQ1999-07-30
37871254871818K991055OSTEONICS SPINAL SYSTEM- ROD/ PLATE SYSTEMMNH1999-08-27
37871018676568K990922OSTEONICS SPINAL SYSTEM VERSATILE CROSS CONNECTORKWP1999-06-02
37871421638409K990059OSTEONICS SPINAL SYSTEM-EXPANDED INDICATIONSMNI1999-01-28
37871613252361K984375OSTEONICS SPINAL SYSTEM - SACRAL OFFSET CONNECTOR ASSEMBLYKWP1999-04-30
37871633210343K984302OSTEONICS SPINAL SYSTEM CYLINDRICAL BONE SCREWSMNH1998-12-18
3391661518722340K984251XIA SPINE SYSTEMKWQ1999-02-24
37831781847622K984251XIA SPINE SYSTEMKWQ1999-02-24
37871781847622K984251XIA SPINE SYSTEMKWQ1999-02-24
37871492839095K983152OSTEONICS SPINAL SYSTEM 5.5MM & 10.0MM BONE SCREWSMNH1998-09-25
3391661304268302K982494BWM SPINE SYSTEMKWP1998-09-08
37831384171796K982494BWM SPINE SYSTEMKWP1998-09-08
37871384171796K982494BWM SPINE SYSTEMKWP1998-09-08
37871614302046K981452OSTEONICS LONG ARM CONTAINMENT RINGKWP1998-05-20
37871921220494K964544OSTEONICS SPINAL SYSTEM - VARIABLE OFFSET CONNECTOR ASSEMBLYMNH1997-02-11
37831048033721K951725OSTEONICS SPINAL SYSTEMMNH1995-09-08
37871048033721K951725OSTEONICS SPINAL SYSTEMMNH1995-09-08
3391661739619929K951725OSTEONICS SPINAL SYSTEMMNH1995-09-08
37871121240506K930009STRYKER 2S SPINAL SYSTEMKWP1994-09-01
3391661446604124K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System; MESA® Spinal System; MESA® Small Stature Spinal System; CASPIAN® Spinal System; DENALI® Spinal System; DENALI® MI Spinal System; YUKON OCT Spinal System; Xia® 3 Spinal System; K2M Patient Specific; CASCADIA™ Interbody System; CAYMAN® Plate System; CAYMAN® Plate System-MIKWQ2024-11-07
3391662046708289K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato® Spinal System, XIA® Growth Rod Conversion Set, XIA® II Spinal System, XIA® Precision System, XIA® Anterior, Diapason® Spinal System, Opus™ Spinal System, Radius® Spinal System, Mantis® Spinal System, Mantis® Redux, Trio® & Trio+ Spinal Fixation System, ES2™ Spinal System, ES2™ Augmentable Spinal System, Oasys® Occipito-Cervico-Thoracic System, Nile® Proximal Fixation Spinal System, Nile® Alternative FiNKB2023-06-08
3391661411114363K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior Cervical Plating (ACP) System, Reflex™ Hybrid ACP System, UniVise™ Spinous Process Fixation PlateKWQ2022-10-19
3391661956787222K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior Lumbar Cage, Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage, Stryker Spine VLIFT Vertebral Body Replacement System, VLIFT-s Vertebral Body Replacement System, Ascential IBD PEEKc Spacer, Aero-AL Lumbar Cage System, Aero-LL Lumbar Cage System, Aero-C Cervical Cage System, AVS Aria PEEK Spacer, AVS Anchor-C Cervical Cage System, AVS Anchor-L SpacerODP2023-02-14
3391661250111888K201585Monterey AL Interbody SystemOVD2020-08-10
37871335231462K190179SAHARA Stabilization SystemOVD2019-10-03
3391661818894635K190179SAHARA Stabilization SystemOVD2019-10-03
3391661340794482K183381Navigation Enabled InstrumentsOLO2019-05-17
37871449412688K183381Navigation Enabled InstrumentsOLO2019-05-17
37871369384524K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar CageMAX2019-07-25
3391662023305889K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar CageMAX2019-07-25
3391661340818797K182473PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate System, CAYMAN Thoracolumbar and Buttress Plate SystemsKWQ2018-12-12
3391661637673357K181014Tritanium PL CageMAX2018-07-18
37871744229967K181014Tritanium PL CageMAX2018-07-18
37871625587071K173476Tritanium® TL Curved Posterior Lumbar CageMAX2018-01-18
3391661883238266K173476Tritanium® TL Curved Posterior Lumbar CageMAX2018-01-18
3391661461423666K172724XIA® 4.5 Spinal System, Power Adaptor Instrument AccessoryNKB2017-10-10
37871497706055K172724XIA® 4.5 Spinal System, Power Adaptor Instrument AccessoryNKB2017-10-10
37871165214150K172034Stryker Spine Navigation System with SpineMap 3D software application, OrthoLock, nGenius Spine Clamp, Navigated Drill Guide Set, Navigated Xia 3 Awl Tap, Navigated Xia 3 Serrato TapOLO2017-10-18
3391661348343520K172034Stryker Spine Navigation System with SpineMap 3D software application, OrthoLock, nGenius Spine Clamp, Navigated Drill Guide Set, Navigated Xia 3 Awl Tap, Navigated Xia 3 Serrato TapOLO2017-10-18
37871435572248K171807ES2 Neuromonitoring Accessory InstrumentsPDQ2017-07-18
3391661498476431K171807ES2 Neuromonitoring Accessory InstrumentsPDQ2017-07-18
37871399710126K171496Tritanium C Anterior Cervical CageODP2017-09-06
3391661440028771K171496Tritanium C Anterior Cervical CageODP2017-09-06
37831851827422K170496Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryNKB2017-05-16
37871851827422K170496Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryNKB2017-05-16
3391661955297825K170496Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryNKB2017-05-16
3391661517675129K162262Tritanium® PL CageMAX2016-11-09
37871952817824K162262Tritanium® PL CageMAX2016-11-09
37831513026100K161569Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex ScrewsLPH2016-10-14
37871249269720K161447HydroSet XTMQV2016-10-06
37871614758854K161407Ascential IBD PEEKc SpacerODP2016-07-15
3391661905559966K161407Ascential IBD PEEKc SpacerODP2016-07-15
3391661322200118K160978LITe BIO Delivery SystemFMF2016-07-08
37871467777225K160978LITe BIO Delivery SystemFMF2016-07-08
37871695331712K160955Tritanium® PL CageMAX2016-07-21
3391661953591562K160955Tritanium® PL CageMAX2016-07-21
37871843976746K160715AccuLIF TL and PL CageMAX2016-07-08
3391661161106344K153608Vitoss BiModal Bone Graft Substitute Foam StripMQV2016-02-12
37871728745668K153608Vitoss BiModal Bone Graft Substitute Foam StripMQV2016-02-12
37871171772476K153306Imbibe NeedleKNW2015-12-18
3391661337134799K153306Imbibe NeedleKNW2015-12-18
37871138251489K152651AccuLIF TL and PL CageMAX2015-12-15
3391661226922428K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryNKB2015-12-02
37871952746820K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryNKB2015-12-02
37871381133350K152532AERO -C Cervical Cage SystemODP2015-12-18
3391661867515315K152532AERO -C Cervical Cage SystemODP2015-12-18
37871325269160K152304Tritanium PL CageMAX2015-11-19
3391661543784580K151755OASYS(r) SystemNKG2015-07-09
37871747364252K151755OASYS(r) SystemNKG2015-07-09
37831178258259K151726AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK Spacer, AVS Navigator PEEK Spacer, AVS ARIA PEEK SpacerMAX2016-01-20
37871178258259K151726AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK Spacer, AVS Navigator PEEK Spacer, AVS ARIA PEEK SpacerMAX2016-01-20
3391661919653918K151726AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK Spacer, AVS Navigator PEEK Spacer, AVS ARIA PEEK SpacerMAX2016-01-20
37871336523214K150753OASYS SystemKWP2015-06-09
3391661398479317K150753OASYS SystemKWP2015-06-09
37872016172902K150700ACP 1 Anterior Cervical Plating SystemKWQ2015-07-15
3391661264771847K150539OASYS SystemNKG2015-05-12
37871674036583K150539OASYS SystemNKG2015-05-12
37831160385141K150449LITe Plate SystemKWQ2015-03-20
37871160385141K150449LITe Plate SystemKWQ2015-03-20
37871244784868K143616AccuLIF TL and PL CageMAX2015-03-05
37871065796249K143597Navigated XIA 4.5 Polyaxial ScrewdriverOLO2015-09-04
3391661137455913K143597Navigated XIA 4.5 Polyaxial ScrewdriverOLO2015-09-04
3391661039819085K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer, AVS® Navigator PEEK Spacer, AVS® ARIA PEEK Spacer, AccuLIF TL and PL Cage, AVS® Anchor-L Spacer, Aero-AL Lumbar Cage SystemOVD2015-01-26
37831975740892K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer, AVS® Navigator PEEK Spacer, AVS® ARIA PEEK Spacer, AccuLIF TL and PL Cage, AVS® Anchor-L Spacer, Aero-AL Lumbar Cage SystemOVD2015-01-26
37871975740892K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer, AVS® Navigator PEEK Spacer, AVS® ARIA PEEK Spacer, AccuLIF TL and PL Cage, AVS® Anchor-L Spacer, Aero-AL Lumbar Cage SystemOVD2015-01-26
3391661327135499K142741OASYS SystemKWP2015-01-15
37871529437701K142741OASYS SystemKWP2015-01-15
37832015949222K142699LITe Plate SystemKWQ2014-12-31
37872015949222K142699LITe Plate SystemKWQ2014-12-31
3391661059913002K142381Xia 3 Spinal SystemNKB2014-10-21
37831462194875K142381Xia 3 Spinal SystemNKB2014-10-21
37871462194875K142381Xia 3 Spinal SystemNKB2014-10-21
37871289356737K142251AVS AS PEEK SpacerODP2014-11-19
3391661971990557K142251AVS AS PEEK SpacerODP2014-11-19
3391661048549618K142237Aviator Anterior Cervical Plate (ACP) SystemKWQ2015-01-26
37872067016172K142237Aviator Anterior Cervical Plate (ACP) SystemKWQ2015-01-26
3391661301178408K142114Xia® Growth Rod Conversion SetPGM2014-10-27
37871641690872K142114Xia® Growth Rod Conversion SetPGM2014-10-27
3391661674135628K142066AERO-LL LUMBAR CAGE SYSTEMOVD2014-11-13
37871731814327K142066AERO-LL LUMBAR CAGE SYSTEMOVD2014-11-13
37871476266145K141941SPINEMASK TRACKER, SPINEMAP 3D 3.0-SOFTWARE,SPINEMAP 3D 3.0-UPGREADE, SPINEMAP 3D 3.0-ENABLE, SPINEMAP 3D 3.0-SALES DOLO2014-10-31
3391661258610156K141217ACCULIF TL AND PL CAGEMAX2014-07-16
37871727647833K141217ACCULIF TL AND PL CAGEMAX2014-07-16
3391661520993026K140868STRYKER KWIC NEEDLEHAW2014-06-05
37871966768487K140868STRYKER KWIC NEEDLEHAW2014-06-05
37871959404397K140576Y WIRE 2HXI2014-05-20
3391662048905830K140576Y WIRE 2HXI2014-05-20
37871959247804K140414IMBIBE NEEDLELXH2014-04-01
3391661271586224K140400ES2 NEUROMONITORING ACCESSORY INSTRUMENTSETN2014-07-01
37871826009969K140400ES2 NEUROMONITORING ACCESSORY INSTRUMENTSETN2014-07-01
37871144142061K133328AERO-AL LUMBAR CAGE SYSTEMOVD2014-05-30

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NKB622023-06-08
MAX502019-07-25
KWQ382024-11-07
KWP382015-06-09
MNH232010-03-18
MNI212008-02-14
MQV182016-10-06
MQP142009-11-02
OVD132020-08-10
ODP112023-02-14
OLO72019-05-17
FMF52016-07-08
HAW52014-06-05
NKG42015-07-09
KNW32015-12-18
OVE32011-04-22
PDQ22017-07-18
PGM22014-10-27
ETN22014-07-01
HXI22014-05-20
FST22012-11-01
NQW22012-04-16
LYC22010-09-27
MRW22003-08-22
LPH12016-10-14
LXH12014-04-01
PEK12013-11-18
NDN12009-06-05
PMX12006-06-16

PMA#

PMN#

73 records. Showing 1-40. Next