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Data / Medical devices / South Korea / Osteonic Co., Ltd.

Osteonic Co., Ltd.: FDA-registered device maker in Seoul, South Korea, 20 510(k) clearances

Osteonic Co., Ltd. is registered with the FDA (registration 3011530718) in Seoul, South Korea. It lists 30 device types. The FDA files 20 510(k) clearances under its listings, the newest dated February 26, 2026. Registered through 2027. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Osteonic Co., Ltd.
FDA registration number
3011530718
Address
405Ho,505-2Ho,505-3Ho,508Ho,603Ho,706Ho,902Ho,1004Ho,1005Ho,1103Ho,12F, 38, Digital-ro 29-gil, Guro-gu 102Ho, 103Ho,105Ho, 24, Digital-ro 27-gil, Guro-gu, 1012Ho, 1013Ho, 272, Digital-ro, Guro-gu, Seoul, South Korea, 08381
Owner or operator
OSTEONIC Co., Ltd. (10048673)
Roles
Exporter to the US, Manufacturer
First device listed
February 10, 2015
Registered through
2027
Brand names listed
110045254, 110045255, 110045256, 110045257, 110045261, 110045263, 110045265, 110045267 and more

Devices it lists

DeviceProduct codeClassRoleSource
Antisera, All Leptospira Spp.GRX2Manufactureraccessdata.fda.gov
Appliance, Fixation, Spinal Intervertebral BodyKWQ2Manufactureraccessdata.fda.gov
AwlHWJ1Manufactureraccessdata.fda.gov
BenderHXW1Manufactureraccessdata.fda.gov
Bit, DrillHTW1Manufactureraccessdata.fda.gov
Chisel, Surgical, ManualFZO1Manufactureraccessdata.fda.gov
Cover, Burr HoleGXR2Manufactureraccessdata.fda.gov
Cutter, SurgicalFZT1Manufactureraccessdata.fda.gov
Fastener, Fixation, Biodegradable, Soft TissueMAI2Manufactureraccessdata.fda.gov
Fastener, Fixation, Nondegradable, Soft TissueMBI2Manufactureraccessdata.fda.gov
Fastener, Plate, CranioplastyHBW2Manufactureraccessdata.fda.gov
ForcepsHTD1Manufactureraccessdata.fda.gov
Gauge, DepthHTJ1Manufactureraccessdata.fda.gov
Guide, Surgical, InstrumentFZX1Manufactureraccessdata.fda.gov
Implant, Endosseous, OrthodonticOAT2Manufactureraccessdata.fda.gov
Instrument, Bending Or ContouringHXP1Manufactureraccessdata.fda.gov
Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/AttachmentKIJ1Exporter to the US, Manufactureraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Manufactureraccessdata.fda.gov
Plate, BoneJEY2Manufactureraccessdata.fda.gov
Plate, Cranioplasty, Preformed, AlterableGWO2Manufactureraccessdata.fda.gov
Plate, Fixation, BoneHRS2Manufactureraccessdata.fda.gov
Punch, SurgicalLRY1Manufactureraccessdata.fda.gov
Retainer, Screw Expansion, OrthodonticDYJ1Manufactureraccessdata.fda.gov
RetractorGAD1Manufactureraccessdata.fda.gov
Screw, Fixation, BoneHWC2Manufactureraccessdata.fda.gov
Screw, Fixation, IntraosseousDZL2Manufactureraccessdata.fda.gov
ScrewdriverHXX1Manufactureraccessdata.fda.gov
Screwdriver, SkullplateGXL1Manufactureraccessdata.fda.gov
Tap, BoneHWX1Manufactureraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
February 26, 2026K254182AsterKWQSubstantially EquivalentOsteonic Co., Ltd.accessdata.fda.gov
May 29, 2025K243469SIGNEXHRSSubstantially EquivalentOsteonic Co., Ltd.accessdata.fda.gov
December 3, 2024K243470Fix2Lock (PEEK Self Punching)MBISubstantially EquivalentOsteonic Co., Ltd.accessdata.fda.gov
December 3, 2024K243467Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)MAISubstantially EquivalentOsteonic Co., Ltd.accessdata.fda.gov
June 11, 2024K230546SIGNEXHRSSubstantially EquivalentOsteonic Co., Ltd.accessdata.fda.gov
December 26, 2023K233659Suture WingMBISubstantially EquivalentOsteonic Co., Ltd.accessdata.fda.gov
June 7, 2023K231322Fix2Lock(PEEK Self Punching)MBISubstantially EquivalentOsteonic Co., Ltd.accessdata.fda.gov
May 31, 2023K231326Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punching)MAISubstantially EquivalentOsteonic Co., Ltd.accessdata.fda.gov
January 27, 2022K210360Neuro 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)GWOSubstantially EquivalentOsteonic Co., Ltd.accessdata.fda.gov
October 15, 2021K211992Ortho MI SystemOATSubstantially EquivalentOsteonic Co., Ltd.accessdata.fda.gov
August 27, 2021K210122Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw)MAISubstantially EquivalentOsteonic Co., Ltd.accessdata.fda.gov
June 17, 2021K202806Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)MAISubstantially EquivalentOsteonic Co., Ltd.accessdata.fda.gov
June 7, 2021K202663Suture WingMBISubstantially EquivalentOsteonic Co., Ltd.accessdata.fda.gov
June 4, 2021K202763Fix2Lock (PEEK Self Punching)MBISubstantially EquivalentOsteonic Co., Ltd.accessdata.fda.gov
November 25, 2020K202883Sterile bone screw (PEEK ACL screw)MBISubstantially EquivalentOsteonic Co., Ltd.accessdata.fda.gov
November 27, 2019K190811Optimus NEURO System - Sterile KitGWOSubstantially EquivalentOsteonic Co., Ltd.accessdata.fda.gov
January 2, 2019K183352Optimus Neuro SystemGWOSubstantially EquivalentOsteonic Co., Ltd.accessdata.fda.gov
October 20, 2016K160363OPTIMUS CMF SYSTEMJEYSubstantially EquivalentOsteonic Co., Ltd.accessdata.fda.gov
February 10, 2015K141911OPTIMUS NEURO SYSTEMGWOSubstantially EquivalentOsteonic Co., Ltd.accessdata.fda.gov
January 20, 2015K140037OPTIMUS CMF SYSTEMJEYSubstantially EquivalentOsteonic Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated February 26, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.