Data / Medical devices / South Korea / Medifield Medical Co., Ltd.
Medifield Medical Co., Ltd.: FDA-registered device maker in Pocheon Gyeonggi, South Korea, 1 510(k) clearance
Medifield Medical Co., Ltd. is registered with the FDA (registration 3033519208) in Pocheon Gyeonggi, South Korea. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 4, 2025. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3033519208
- Address
- 94-40, Yongjeonggyeongje-ro 1-gil, Gunnae-myeon, Pocheon-si, Gyeonggi-do 1st floor, Gadong, Pocheon Gyeonggi, South Korea, 11154
- Owner or operator
- MEDIFIELD MEDICAL CO., LTD. (10091668)
- Roles
- Manufacturer
- First device listed
- October 28, 2024
- Registered through
- 2026
- Brand names listed
- AO Type Handle, Cortical Drill Guide; Ankle, Cortical Drill Guide; Radius, Depth Gauge; Blue, Depth Gauge; Green, Drill Bit; 2.7mm, Drill Bit; 2mm, Driver Shaft; 3.5mm and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Orthopedic Manual Surgical Instrument | LXH | 1 | Manufacturer | accessdata.fda.gov |
| Plate, Fixation, Bone | HRS | 2 | Manufacturer | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Manufacturer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Manufacturer | accessdata.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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 4, 2025 | K243368 | Montblanc Plate System | HRS | Substantially Equivalent | Medifield Medical Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Screw, Fixation, Bone
- All makers of Plate, Fixation, Bone
- All makers of Tray, Surgical, Instrument
- All makers of Orthopedic Manual Surgical Instrument
Updated June 4, 2025. 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.