CG BIO CO., LTD.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3017036472	3017036472	CG BIO CO., LTD.	1	N	2026-01-01	Part of C-dong, Part of D-dong 29, Jeyakdanji-ro, Hyangnam-eup, Manse-gu Hwaseong-si Gyeonggi KR 18608
3008679610	3006724198	CG BIO CO., LTD.	1	N	2020-04-25	244, Galmachi-ro, Jungwon-gu, Seongnam-si Gyeonggido KR 13211

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
293248	1605758719	K252251	EASYMADE-TI	GXN	2026-04-09
293248	1555174541	K250582	COLONNADE Posterior Screw Fixation System	NKB	2025-05-08
293248	1198628100	K222229	Advanced LumFix Spinal Fixation System	NKB	2023-05-25
142048	1263126274	K160731	LumFix Spinal Fixation Sytem	MNI	2016-10-04
293248	1263126274	K160731	LumFix Spinal Fixation Sytem	MNI	2016-10-04
293248	1165887758	K122490	KULAVAC	OMP	2013-11-13
293248	1458019238	K090793	BONGROS HA	LYC	2009-05-19
142048	1093644438
142048	1773654334
293248	1093644438
293248	1165887758
293248	1376616400
293248	1466530389
293248	1752860444
293248	1757783852
293248	1773654334
293248	1895760397

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
GXN	2	2026-04-09
NKB	2	2025-05-08
MNI	2	2016-10-04
OMP	1	2013-11-13
LYC	1	2009-05-19

PMN#

Advanced LumFix Spinal Fixation System
2023-05-25
CG Bio Co., Ltd.
LumFix Spinal Fixation Sytem
2016-10-04
CG BIO CO., LTD.

GUDID#

LumFix spinal fixation system - Regulation Name : Pedicle screw spinal system
CG Bio Co., Ltd.
2021-02-03
LumFix spinal fixation system - Regulation Name : Pedicle screw spinal system
CG Bio Co., Ltd.
2020-07-27
LumFix Spinal Fixation System - Regulation Name: Pedicle screw spinal system
CG Bio Co., Ltd.
2017-01-31
LumFix Spinal Fixation System - Regulation Name: Pedicle screw spinal system
CG Bio Co., Ltd.
2019-12-02
LumFix Spinal Fixation System - Pedicle Screw Spinal System
CG Bio Co., Ltd.
2019-10-30
LumFix Spinal Fixation System - Regulation Name: Pedicle screw spinal system
CG Bio Co., Ltd.
2019-10-18
LumFix Spinal Fixation System - Regulation Name: Pedicle screw spinal system
CG Bio Co., Ltd.
2019-10-18
LumFix Spinal Fixation System - Regulation Name: Pedicle screw spinal system
CG Bio Co., Ltd.
2019-10-18
LumFix Spinal Fixation System - Regulation Name: Pedicle screw spinal system
CG Bio Co., Ltd.
2019-10-18
LumFix Spinal Fixation System - Regulation Name: Pedicle screw spinal system
CG Bio Co., Ltd.
2019-10-18
LumFix Spinal Fixation System - Regulation Name: Pedicle screw spinal system
CG Bio Co., Ltd.
2019-10-18
LumFix Spinal Fixation System - Regulation Name: Pedicle screw spinal system
CG Bio Co., Ltd.
2019-10-18
LumFix Spinal Fixation System - Regulation Name: Pedicle screw spinal system
CG Bio Co., Ltd.
2019-10-18
LumFix Spinal Fixation System - Regulation Name: Pedicle screw spinal system
CG Bio Co., Ltd.
2019-10-18
LumFix Spinal Fixation System - Regulation Name: Pedicle screw spinal system
CG Bio Co., Ltd.
2019-10-18
LumFix Spinal Fixation System - Regulation Name: Pedicle screw spinal system
CG Bio Co., Ltd.
2019-10-18
LumFix Spinal Fixation System - Regulation Name: Pedicle screw spinal system
CG Bio Co., Ltd.
2019-10-18
LumFix Spinal Fixation System - Regulation Name: Pedicle screw spinal system
CG Bio Co., Ltd.
2019-10-18
LumFix Spinal Fixation System - Regulation Name: Pedicle screw spinal system
CG Bio Co., Ltd.
2019-10-18
LumFix Spinal Fixation System - Regulation Name: Pedicle screw spinal system
CG Bio Co., Ltd.
2019-10-17
LumFix Spinal Fixation System - Regulation Name: Pedicle screw spinal system
CG Bio Co., Ltd.
2019-10-17
LumFix Spinal Fixation System - Regulation Name: Pedicle screw spinal system
CG Bio Co., Ltd.
2019-10-17
LumFix Spinal Fixation System - Regulation Name: Pedicle screw spinal system
CG Bio Co., Ltd.
2019-10-17
LumFix Spinal Fixation System - Regulation Name: Pedicle screw spinal system
CG Bio Co., Ltd.
2019-10-17
LumFix Spinal Fixation System - Regulation Name: Pedicle screw spinal system
CG Bio Co., Ltd.
2019-10-17
LumFix Spinal Fixation System - Regulation Name: Pedicle screw spinal system
CG Bio Co., Ltd.
2019-10-17
LumFix Spinal Fixation System - Regulation Name: Pedicle screw spinal system
CG Bio Co., Ltd.
2019-10-17
LumFix Spinal Fixation System - Regulation Name: Pedicle screw spinal system
CG Bio Co., Ltd.
2019-10-17
LumFix Spinal Fixation System - Regulation Name: Pedicle screw spinal system
CG Bio Co., Ltd.
2019-10-17
LumFix Spinal Fixation System - Regulation Name: Pedicle screw spinal system
CG Bio Co., Ltd.
2019-10-17
LumFix Spinal Fixation System - Regulation Name: Pedicle screw spinal system
CG Bio Co., Ltd.
2019-10-17
LumFix Spinal Fixation System - Regulation Name: Pedicle screw spinal system
CG Bio Co., Ltd.
2019-10-17
LumFix Spinal Fixation System - Regulation Name: Pedicle screw spinal system
CG Bio Co., Ltd.
2019-10-17
LumFix Spinal Fixation System - Regulation Name: Pedicle screw spinal system
CG Bio Co., Ltd.
2019-10-17
LumFix Spinal Fixation System - Regulation Name: Pedicle screw spinal system
CG Bio Co., Ltd.
2019-10-17
LumFix Spinal Fixation System - Regulation Name: Pedicle screw spinal system
CG Bio Co., Ltd.
2019-10-17
LumFix Spinal Fixation System - Regulation Name: Pedicle screw spinal system
CG Bio Co., Ltd.
2019-10-17
LumFix Spinal Fixation System - Regulation Name: Pedicle screw spinal system
CG Bio Co., Ltd.
2019-10-17
LumFix Spinal Fixation System - Regulation Name: Pedicle screw spinal system
CG Bio Co., Ltd.
2019-10-17
LumFix Spinal Fixation System - Regulation Name: Pedicle screw spinal system
CG Bio Co., Ltd.
2019-10-17

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