FDA.reportPublic FDA data

STRYKER SPINE SARL

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
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
37831781847622K984251XIA SPINE SYSTEMKWQ1999-02-24
37831384171796K982494BWM SPINE SYSTEMKWP1998-09-08
37831048033721K951725OSTEONICS SPINAL SYSTEMMNH1995-09-08
37831851827422K170496Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryNKB2017-05-16
37831513026100K161569Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex ScrewsLPH2016-10-14
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
37831160385141K150449LITe Plate SystemKWQ2015-03-20
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
37832015949222K142699LITe Plate SystemKWQ2014-12-31
37831462194875K142381Xia 3 Spinal SystemNKB2014-10-21
37831991898517K133188MANTIS & MANTIS REDUX SPINAL SYSTEM, RADIUS SPINAL SYSTEM, TRIO & TRIO+ SPINAL FIXATION SYSTEMS, AND TRIO TRAUMA SPINALNKB2013-12-17
37831087854899K120869ANCHOR-L LUMBAR CAGEOVD2012-10-25
37831854656642K113666XIA 3 SPINAL SYSTEMNKB2012-08-28
37831599924485K102606AVS ANCHOR-C CERVICAL CAGE SYSTEMOVE2011-04-22
37831265679879K101051AVS A-LAT PEEK SPACERS, MODELS 48750XXX, 48751XXX, 48752XXX, 48753XXXMAX2010-08-12
37831856201911K083393XIA 3 SPINAL SYSTEMNKB2009-04-01
37831561099151K071373STRYKER SPINE XIA III SPINAL SYSTEMNKB2007-08-27
37831616499086K060979XIA TITANIUM AND 4.5 SPINAL SYSTEMSNKB2006-05-19
37831688862743K060361XIA SPINAL SYSTEM, XIA 4.5 SPINAL SYSTEMNKB2006-03-06
37831000085136K053115XIA SPINAL SYSTEMMNI2005-12-06
37831049648201K052181MODIFICATION TO XIA SPINAL SYSTEMKWP2005-09-08
37831430847039K051973MODIFICATION TO: XIA STAINLESS STEEL SYSTEMKWP2005-08-18
37831641727337K031893XIA SPINAL SYSTEM AND XIA STAINLESS STEEL SYSTEMKWP2003-07-17
37831984817195K031090MODIFICATION TO XIA STAINLESS STEEL SYSTEMKWP2003-04-24
37831097160067K022160XIA SPINAL SYSTEMMNI2002-08-01
37832027200660K013823XIA SPINAL SYSTEMKWP2001-12-19
37831035300085K012870XIA STAINLESS STEEL SYSTEMKWP2001-09-24
37832062649638K012027MODIFICATION TO XIA SPINE SYSTEMMNH2001-07-20
37831329529518K002858XIA SPINE SYSTEMKWQ2000-10-13
37831783368597K001653XIA SPINE SYSTEM SACRAL BLOCK ASSEMBLYKWP2000-08-18

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NKB82017-05-16
KWP82005-09-08
KWQ42015-03-20
MAX22016-01-20
OVD22015-01-26
MNI22005-12-06
MNH22001-07-20
LPH12016-10-14
OVE12011-04-22