FDA.reportPublic FDA data

OSTEONIC CO., LTD.

Matched from indexed company URL: Osteonic Co., Ltd.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30115307183011530718OSTEONIC CO., LTD.1N2026-01-01405Ho,505-2Ho,505-3Ho,508Ho,603Ho,706Ho,902Ho,1004Ho,1005Ho,1103 102Ho, 103Ho,105Ho, 24, Digital-ro 27-gil, Guro- Seoul KR 08381

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
08800071055457ASTER - 1Level, 19mm (H to H 10mm)+821041480931yjlim@osteonic.com
08800071055464ASTER - 1Level, 21mm (H to H 12mm)+821041480931yjlim@osteonic.com
08800071055471ASTER - 1Level, 23mm (H to H 14mm)+821041480931yjlim@osteonic.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1802501546126833K254182AsterKWQ2026-02-26
1802501996490815K243470Fix2Lock (PEEK Self Punching)MBI2024-12-03
1802501042730513K243469SIGNEXHRS2025-05-29
1802501905521013K243467Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)MAI2024-12-03
1802501781021999K233659Suture WingMBI2023-12-26
1802501641508304K231326Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punching)MAI2023-05-31
1802501116412604K231322Fix2Lock(PEEK Self Punching)MBI2023-06-07
1802501492454691K230546SIGNEXHRS2024-06-11
1802501488602023K211992Ortho MI SystemOAT2021-10-15
1802501446846902K210360Neuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models), Neuro Plating System-Packaging unit(NSP-001 and 10 models), Neuro Plating System-Sterile Kit(TCN-011 and 69 models), Neuro Plating System-Screws(N15A03 and 11 models)GWO2022-01-27
1802501454042965K210122Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw)MAI2021-08-27
1802501661629492K202883Sterile bone screw (PEEK ACL screw)MBI2020-11-25
1802501816429771K202806Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)MAI2021-06-17
1802501907375763K202763Fix2Lock (PEEK Self Punching)MBI2021-06-04
1802501679126375K202663Suture WingMBI2021-06-07
1802501886886973K190811Optimus NEURO System - Sterile KitGWO2019-11-27
1802501978794216K183352Optimus Neuro SystemGWO2019-01-02
1802501662065464K160363OPTIMUS CMF SYSTEMJEY2016-10-20
1802501925790595K141911OPTIMUS NEURO SYSTEMGWO2015-02-10
1802501234618941K140037OPTIMUS CMF SYSTEMJEY2015-01-20
1802501186817214
1802501012053227
1802501055571063
1802501192177254
1802501235053000
1802501287262731
1802501411019994
1802501412528715
1802501460624216
1802501575570304
1802501671641131
1802501822596669
1802501839324993
1802501845189902
1802501942802574
1802501980873655
1802502038027825
1802502038785643
1802502060208882

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MBI62024-12-03
MAI42024-12-03
GWO42022-01-27
HRS22025-05-29
JEY22016-10-20
KWQ12026-02-26
OAT12021-10-15

PMN#

GUDID#

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