FDA.reportPublic FDA data

GS MEDICAL CO., LTD.

Matched from indexed company URL: GS Medical Co. Ltd.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30055965143005596514GS MEDICAL CO., LTD.1N2026-01-0190, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu, Cheongju-si Chungbuk KR 28161

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
08809885799847QUASAR Standalone ACIF System - Quasar Trial Without Stopper+82432377393udimail@gsmedi.com
08809885799854QUASAR Standalone ACIF System - Quasar Trial Without Stopper+82432377393udimail@gsmedi.com
08809885799861QUASAR Standalone ACIF System - Quasar Trial Without Stopper+82432377393udimail@gsmedi.com
08809885799878QUASAR Standalone ACIF System - Quasar Trial Without Stopper+82432377393udimail@gsmedi.com
08809885799885QUASAR Standalone ACIF System - Quasar Trial Without Stopper+82432377393udimail@gsmedi.com
08809885799892QUASAR Standalone ACIF System - Quasar Trial Without Stopper+82432377393udimail@gsmedi.com
08809974806104PYXIS 3D Titanium Cage System - OLIF II Trial+82432377393udimail@gsmedi.com
08809974815793PYXIS 3D Titanium Cage System - 3D OLIF II Thread Inserter+82432377393udimail@gsmedi.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
246661963016234K241738PYXIS 3D Titanium Cervical Cage systemODP2024-08-20
246661350511620K240350AnyPlus II Spinal Fixation SystemNKB2024-04-03
246661331943852K231808QUASAR Standalone ACIF SystemOVE2023-07-20
246661193753894K223868PYXIS 3D Titanium Cage SystemMAX2023-04-26
246661007093447K222041CYGNUS-C Standalone ACIF SystemOVE2023-02-09
246662020579464K221687Pegasus-X Expandable PLIF SystemMAX2022-07-27
246661875336794K211797TRACKER Plus Kyphoplasty SystemNDN2021-10-28
246661215151188K200592GS Medical AnyPlus PEEK Cage SystemODP2020-08-10
246661913322128K192335TRACKER Kyphoplasty SystemNDN2019-12-04
246661010572690K190170MVP Cervical Plate SystemKWQ2019-05-13
246661362498611K172546AnyPlus® Spinal Fixation SystemNKB2017-10-23
246661068537660K153517AnyPlus® Cervical PEEK Cage SystemODP2016-06-24
246661213988620K131612ANYPLUS; ALIF PEEK CAGES, PLIF PEEK CAGES, T-PLIF PEEK CAGES, TLIF PEEK CAGESMAX2014-04-18
246662019633316K111354GS MEDICAL ANYPLUS PEEK LUMBAR CAGES (ALIF AND DLIF)MAX2011-10-17
246661868605518K100516ANYPLUS PEEK CAGESOVD2010-12-03
246661060861334K091717ANY PLUS SPINAL FIXATION SYSTEMNKB2010-01-25
246661563667904K053573GSS PEDICLE SCREW SYSTEMMNH2006-03-08
246661056143608
246661069842853
246661105869070
246661139868576
246661164934362
246661285553424
246661317259395
246661395524288
246661408408137
246661432883829
246661433210132
246661469887659
246661475595817
246661512130079
246661513519882
246661622354712
246661700566215
246661732746028
246661754010167
246661763941910
246661792341854
246661816828525
246661843046950
246661908707179
246661908843795
246661930852003
246661979413365

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MAX62023-04-26
NKB52024-04-03
ODP42024-08-20
NDN32021-10-28
OVE22023-07-20
KWQ22019-05-13
OVD22010-12-03
MNH22006-03-08

PMN#

GUDID#

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