FDA.reportPublic FDA data

MEDYSSEY CO., LTD.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30074851693007485169MEDYSSEY CO., LTD.1N2026-01-01129, Hanbang expo-ro Jecheon-si, Chungcheongbuk-do Jecheon-si Chungbuk KR 27116

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
989461304070370K260036NeckTune™ 3D SA Cervical CageOVE2026-06-15
989461493489528K242806Medyssey Navigation SystemOLO2025-04-16
989461044325367K232218Zenius™ Spinal SystemNKB2023-08-24
989461468134157K230301Athena III Cervical Plate SystemKWQ2023-03-07
989461250863508K223654Medussa-PL CageMAX2022-12-28
989461120363475K200283Medussa-PL CageMAX2020-06-18
989461552056474K183409Athena II Cervical Plate SystemKWQ2019-02-11
989461605086259K183407Triton CageMAX2019-08-30
989461186301824K181978Zenius™, Iliad™ and Kora™ Spinal Fixation SystemsNKB2018-08-13
989461522429258K180022Athena Cervical Plate SystemKWQ2018-07-20
989461219792394K172756Varian cageMAX2017-12-08
989461348595150K171526Zenius™, lliad™ and Kora™ Spinal Fixation SystemsNKB2017-08-21
989461695277341K171509Iliad® Pedicle Screw System and Zenius® Pedicle Screw SystemNKB2017-06-12
989461490743746K170964Zenius Spinal SystemNKB2017-04-26
989461045291127K170389TAURUS PEEK Cage SystemMAX2017-12-14
989461846802983K170341Medussa-PL CageMAX2017-11-02
989461603926443K161637Poseidon OCT Spinal Fixation SystemNKG2017-01-05
989461282337225K142835Iliad Pedicle Screw System and Zenius Pedicle Screw SystemNKB2015-06-12
989461210350079K140564BN LUMBAR CAGE SYSTEMMAX2014-06-05
989461413196518K132732MEDYSSEY ANTERIOR CERVICAL FUSION CAGEODP2014-07-18
989461370593796K131878LLIAD, KORA, ZENIUS PEDICLE SCREW SYSTEMNKB2013-08-23
989461036389854K121670MEDYSSEY CANNULATED PEDICLE SCREWNKB2013-01-25
989461385508409K121320C7 ANTERIOR CERVICAL INTERVERTEBRAL FUSION CAGEODP2012-08-10
989461791243578K121246MEDYSSY LT CAGE SYSTEMMAX2012-06-15
989461841598352K110284NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEMMNI2011-06-08
989461019596630K110283ZENIUS SPINAL SYSTEMMNI2011-05-19
989461434822903K110067LP CAGEMAX2011-04-08
989461077858934K103272ZENIUS SPINAL SYSTEMMNI2010-12-29
989461582478261K103147NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEMMNI2010-12-16
989461240358225K093104MEDYSSEY CO., LTD., ZENIUS SPINAL SYSTEMMNI2010-06-25
989461341090149K081153NOVEL SPINAL SYSTEMMNH2009-01-30
989461517513011
989461025958515
989461741554869

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MAX102022-12-28
NKB82023-08-24
MNI52011-06-08
KWQ32023-03-07
ODP22014-07-18
OVE12026-06-15
OLO12025-04-16
NKG12017-01-05
MNH12009-01-30

PMN#

GUDID#

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