FDA.reportPublic FDA data

CG MedTech Co., Ltd.

Matched from indexed company URL: CG MedTech Co.,Ltd.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96172973003200961CG MedTech Co., Ltd.1N2026-01-0120, Sandan-ro 76beon-gil(Rd) Uijeongbu-si Gyeonggi KR 11781

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
198361590205326K252351UniSpace® TPLIF CageMAX2025-10-28
198361128571368K251725ANAX™ OCT Spinal SystemNKG2025-06-25
198361386133406K241082INNOVERSE Navigation InstrumentsOLO2024-06-14
198362018617607K234119UniSpace® Stand-Alone C CageOVE2024-04-19
198361842797169K233960INNOVERSE Spinal SystemNKB2024-02-06
198361652472238K231737ANAX™ 5.5 Spinal SystemNKB2023-10-26
198361178785207K221084Dyna Locking Trochanteric Nail™HSB2023-03-03
198361321954046K220147Aspiron S ACP SystemKWQ2022-02-16
198361250310223K210573Velofix SA Cervical CageOVE2021-11-19
198361972024395K190067Velofix Interbody Fusion SystemODP2019-02-04
198361382468816K190053SECULOK™ ACP SystemKWQ2019-02-01
198361467173693K183383ANAX™ OCT Spinal SystemNKG2018-12-12
198361741070907K183243Velofix TLIF CageMAX2019-07-10
198361376305587K182055SECULOK™ ACP SystemKWQ2018-09-10
198361281925513K181829Velofix TLIF CageMAX2018-11-14
198361184373156K181824CBT Screw Fixation SystemNKB2018-12-13
198361782387569K180759SECULOK™ Suture AnchorMBI2018-08-09
198361518539102K173524ANAX 5.5™ Spinal SystemNKB2017-12-13
198361861688234K173198Facet Screw Fixation SystemMRW2018-01-03
198361917154501K172424Velofix™ SA Cervical CageOVE2017-11-22
198361056515284K172419Velofix™ TLIF CageMAX2017-12-04
198362044650096K171749Velofix(tm) Interbody Fusion SystemODP2017-07-13
198361431766173K162189ANAX™ 5.5 Spinal SystemMNH2016-08-30
198361998336990K150570ANAX OCT Spinal SystemNKG2015-06-03
198361711875875K143631Benefix Interspinous Fixation SystemPEK2015-09-03
198361730714213K143417ANAX 5.5 Spinal SystemMNH2015-02-25
198361074720805K140864VELOXTM INTERBODY FUSION SYSTEMODP2014-07-22
198361620146163K140234ASPIRON ACP SYSTEMKWQ2014-06-02
198361272777931K132926VELOFIXTM INTERBODY FUSION SYSTEMODP2014-03-05
198361324144243K132797L'DISQGEI2014-07-30
198361777223377K132218PERFIX ILIAC SCREW SYSTEMMNH2013-12-17
198361997991370K132101ANAX 5.5 SPINAL SYSTEMMNH2013-11-25
198361744816285K131200ASPIRON ACP SYSTEMKWQ2013-08-29
198361364366307K120760LDR SPINE SPINETUNE TL SPINAL SYSTEMMNH2012-06-27
198361396263281K120419DYNA LOCKING ANKLE NAILHSB2012-05-21
198361182949747K112240DYNA LOCKING CANNULATED SCREWHWC2012-01-04
198361350876255K102367OPTIGEN TOTAL KNEE SYSTEMJWH2010-12-08
198361450179642K102331LDR SPINE USA SPINETUNE TL SPINAL SYSTEMMNI2010-10-15
198361540980704K102265LDR SPINE USA C-PLATE, TL ANTERIOR CERVICAL PLATE SYSTEMKWQ2010-09-29
198361052428514K100575LDR SPINE USA SPINE TUNE TL SPINE SYSTEMMNI2010-03-31
198361176239810K093707DYNA LOCKING TROCHANTERIC NAIL, MODEL NG0820HSB2010-06-23
198361219071957K092771DYNA LOCKING IM NAILHSB2009-12-02
198361286873300K091725PERFIX SPINAL SYSTEM, MODEL SNA4530-9610, SNM4530-9610, SN3020 (TOTAL: 549)MNH2009-11-09
198361869824197K061002MAXIMA ANTERIOR CERVICAL PLATE SYSTEMKWQ2006-11-15
198361249187075K051971OPTIMA SPINAL SYSTEMKWQ2005-08-04
198361407689128K042928MODIFICATION TO GLOBAL SPINAL FIXATION SYSTEMMNH2005-02-17
198361858202109K031595U & I AMERICA SPINAL HOOK SYSTEMKWP2003-06-24
198361171673280K031585U&I, OPTIMA, SPINAL SYSTEMMNH2003-06-27
198361047608383K024096OPTIMA, SPINAL SYSTEMMNI2003-03-12
198362001004481K020279FOREX CORPORATION, OPTIMA, SPINAL SYSTEMMNI2002-06-20
198361131410926
198361471279721
198361033492415
198361055017517
198361122059200
198361180281439
198361225491342
198361249446524
198361281628681
198361394817884
198361427513723
198361501534815
198361563802467
198361566241657
198361641607826
198361680140938
198361724552701
198361755938966
198361789999780
198361844430918
198361850001334
198361875516188
198361998169026
198362026949191
198362060696220

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KWQ82022-02-16
MNH82016-08-30
MAX42025-10-28
NKB42024-02-06
HSB42023-03-03
ODP42019-02-04
MNI42010-10-15
NKG32025-06-25
OVE32024-04-19
OLO12024-06-14
MBI12018-08-09
MRW12018-01-03
PEK12015-09-03
GEI12014-07-30
HWC12012-01-04
JWH12010-12-08
KWP12003-06-24

PMN#

GUDID#

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