FDA.reportPublic FDA data

CG MedTech USA, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30095542933009554293CG MedTech USA, Inc.1Y2026-01-0141 Corporate Park Suite 200 Irvine CA US 92606

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1398481590205326K252351UniSpace® TPLIF CageMAX2025-10-28
1398481128571368K251725ANAX™ OCT Spinal SystemNKG2025-06-25
1398481386133406K241082INNOVERSE Navigation InstrumentsOLO2024-06-14
1398482018617607K234119UniSpace® Stand-Alone C CageOVE2024-04-19
1398481842797169K233960INNOVERSE Spinal SystemNKB2024-02-06
1398481652472238K231737ANAX™ 5.5 Spinal SystemNKB2023-10-26
1398481178785207K221084Dyna Locking Trochanteric Nail™HSB2023-03-03
1398481321954046K220147Aspiron S ACP SystemKWQ2022-02-16
1398481250310223K210573Velofix SA Cervical CageOVE2021-11-19
1398481972024395K190067Velofix Interbody Fusion SystemODP2019-02-04
1398481382468816K190053SECULOK™ ACP SystemKWQ2019-02-01
1398481467173693K183383ANAX™ OCT Spinal SystemNKG2018-12-12
1398481741070907K183243Velofix TLIF CageMAX2019-07-10
1398481376305587K182055SECULOK™ ACP SystemKWQ2018-09-10
1398481281925513K181829Velofix TLIF CageMAX2018-11-14
1398481184373156K181824CBT Screw Fixation SystemNKB2018-12-13
1398481518539102K173524ANAX 5.5™ Spinal SystemNKB2017-12-13
1398481861688234K173198Facet Screw Fixation SystemMRW2018-01-03
1398481917154501K172424Velofix™ SA Cervical CageOVE2017-11-22
1398481056515284K172419Velofix™ TLIF CageMAX2017-12-04
1398482044650096K171749Velofix(tm) Interbody Fusion SystemODP2017-07-13
1398481431766173K162189ANAX™ 5.5 Spinal SystemMNH2016-08-30
1398481998336990K150570ANAX OCT Spinal SystemNKG2015-06-03
1398481711875875K143631Benefix Interspinous Fixation SystemPEK2015-09-03
1398481730714213K143417ANAX 5.5 Spinal SystemMNH2015-02-25
1398481074720805K140864VELOXTM INTERBODY FUSION SYSTEMODP2014-07-22
1398481620146163K140234ASPIRON ACP SYSTEMKWQ2014-06-02
1398481272777931K132926VELOFIXTM INTERBODY FUSION SYSTEMODP2014-03-05
1398481324144243K132797L'DISQGEI2014-07-30
1398481777223377K132218PERFIX ILIAC SCREW SYSTEMMNH2013-12-17
1398481997991370K132101ANAX 5.5 SPINAL SYSTEMMNH2013-11-25
1398481744816285K131200ASPIRON ACP SYSTEMKWQ2013-08-29
1398481396263281K120419DYNA LOCKING ANKLE NAILHSB2012-05-21
1398481182949747K112240DYNA LOCKING CANNULATED SCREWHWC2012-01-04
1398481350876255K102367OPTIGEN TOTAL KNEE SYSTEMJWH2010-12-08
1398481176239810K093707DYNA LOCKING TROCHANTERIC NAIL, MODEL NG0820HSB2010-06-23
1398481219071957K092771DYNA LOCKING IM NAILHSB2009-12-02
1398481286873300K091725PERFIX SPINAL SYSTEM, MODEL SNA4530-9610, SNM4530-9610, SN3020 (TOTAL: 549)MNH2009-11-09
1398481869824197K061002MAXIMA ANTERIOR CERVICAL PLATE SYSTEMKWQ2006-11-15
1398481249187075K051971OPTIMA SPINAL SYSTEMKWQ2005-08-04
1398481407689128K042928MODIFICATION TO GLOBAL SPINAL FIXATION SYSTEMMNH2005-02-17
1398481858202109K031595U & I AMERICA SPINAL HOOK SYSTEMKWP2003-06-24
1398481171673280K031585U&I, OPTIMA, SPINAL SYSTEMMNH2003-06-27
1398481047608383K024096OPTIMA, SPINAL SYSTEMMNI2003-03-12
1398482001004481K020279FOREX CORPORATION, OPTIMA, SPINAL SYSTEMMNI2002-06-20
1398481131410926
1398481471279721
1398481033492415
1398481055017517
1398481122059200
1398481180281439
1398481225491342
1398481249446524
1398481281628681
1398481394817884
1398481427513723
1398481501534815
1398481563802467
1398481566241657
1398481641607826
1398481680140938
1398481724552701
1398481755938966
1398481789999780
1398481844430918
1398481850001334
1398481875516188
1398481998169026
1398482026949191
1398482060696220

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KWQ72022-02-16
MNH72016-08-30
MAX42025-10-28
NKB42024-02-06
HSB42023-03-03
ODP42019-02-04
NKG32025-06-25
OVE32024-04-19
MNI22003-03-12
OLO12024-06-14
MRW12018-01-03
PEK12015-09-03
GEI12014-07-30
HWC12012-01-04
JWH12010-12-08
KWP12003-06-24