Osteonic Co., Ltd.
Seoul, KR
OSTEONIC CO., LTD. appears in FDA device records in Seoul, KR. FDA records list 20 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 20 510(k) clearances for Osteonic Co., Ltd. between 2015 and 2026. The busiest year on record is 2021, with 5. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2015 | 2 |
| 2016 | 1 |
| 2019 | 2 |
| 2020 | 1 |
| 2021 | 5 |
| 2022 | 1 |
| 2023 | 3 |
| 2024 | 3 |
| 2025 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K254182 | Aster | KWQ | Substantially Equivalent | |
| K243469 | SIGNEX | HRS | Substantially Equivalent | |
| K243470 | Fix2Lock (PEEK Self Punching) | MBI | Substantially Equivalent | |
| K243467 | Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) | MAI | Substantially Equivalent | |
| K230546 | SIGNEX | HRS | Substantially Equivalent | |
| K233659 | Suture Wing | MBI | Substantially Equivalent | |
| K231322 | Fix2Lock(PEEK Self Punching) | MBI | Substantially Equivalent | |
| K231326 | Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punching) | MAI | Substantially Equivalent | |
| K210360 | Neuro 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) | GWO | Substantially Equivalent | |
| K211992 | Ortho MI System | OAT | Substantially Equivalent | |
| K210122 | Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw) | MAI | Substantially Equivalent | |
| K202806 | Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) | MAI | Substantially Equivalent | |
| K202663 | Suture Wing | MBI | Substantially Equivalent | |
| K202763 | Fix2Lock (PEEK Self Punching) | MBI | Substantially Equivalent | |
| K202883 | Sterile bone screw (PEEK ACL screw) | MBI | Substantially Equivalent | |
| K190811 | Optimus NEURO System - Sterile Kit | GWO | Substantially Equivalent | |
| K183352 | Optimus Neuro System | GWO | Substantially Equivalent | |
| K160363 | OPTIMUS CMF SYSTEM | JEY | Substantially Equivalent | |
| K141911 | OPTIMUS NEURO SYSTEM | GWO | Substantially Equivalent | |
| K140037 | OPTIMUS CMF SYSTEM | JEY | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3011530718 | 3011530718 | OSTEONIC CO., LTD. | 405Ho,505-2Ho,505-3Ho,508Ho,603Ho,706Ho,902Ho,1004Ho,1005Ho,1103Ho,12F, 38, Digital-ro 29-gil, Guro-gu, Seoul 08381 KR | 2026 | and 20 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- GRXAntisera, All Leptospira Spp.
- KWQAppliance, Fixation, Spinal Intervertebral Body
- HWJAwl
- HXWBender
- HTWBit, Drill
- FZOChisel, Surgical, Manual
- GXRCover, Burr Hole
- FZTCutter, Surgical
- MAIFastener, Fixation, Biodegradable, Soft Tissue
- MBIFastener, Fixation, Nondegradable, Soft Tissue
- HBWFastener, Plate, Cranioplasty
- HTDForceps
- HTJGauge, Depth
- FZXGuide, Surgical, Instrument
- OATImplant, Endosseous, Orthodontic
- HXPInstrument, Bending Or Contouring
- KIJInstrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
- LXHOrthopedic Manual Surgical Instrument
- JEYPlate, Bone
- GWOPlate, Cranioplasty, Preformed, Alterable
- HRSPlate, Fixation, Bone
- LRYPunch, Surgical
- DYJRetainer, Screw Expansion, Orthodontic
- GADRetractor
- HWCScrew, Fixation, Bone
- DZLScrew, Fixation, Intraosseous
- HXXScrewdriver
- GXLScrewdriver, Skullplate
- HWXTap, Bone
- FSMTray, Surgical, Instrument
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Osteonic Co., Ltd. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain