GNI Co., LTD FDA Filings

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3014270297	3014270297	GNI Co., LTD	1	N	2026-01-01	63-12, Dongtancheomdansaneop 1-ro 5F, 501 Hwaseong-si Gyeonggi KR 18465

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
214976	1256623785	K201410	VENUS Bracket, ROSE Bracket	NJM	2021-03-12
214976	1361525259	K191041	Orthodontic Fixation Screw [Smart Anchor Miniscrew]	OAT	2020-08-28
214976	1281938029	K182672	ROSA Bracket	NJM	2019-11-15
214976	1035804900
214976	1037485853
214976	1039872410
214976	1073415815
214976	1098722353
214976	1100963010
214976	1238232558
214976	1257292157
214976	1315918797
214976	1372038425
214976	1375349653
214976	1689993935
214976	1714007331
214976	1743341401
214976	1795812723
214976	1807653707
214976	1872869630
214976	1933542748
214976	1936879841

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
NJM	2	2021-03-12
OAT	1	2020-08-28