Data / Medical devices / South Korea / JMT Co., Ltd.
JMT Co., Ltd.: FDA-registered device maker in Yangju-si Gyeonggi, South Korea, 4 510(k) clearances
JMT Co., Ltd. is registered with the FDA (registration 3021006165) in Yangju-si Gyeonggi, South Korea. It lists 5 device types. The FDA files 4 510(k) clearances under its listings, the newest dated February 13, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3021006165
- Address
- 70-39, Gwonyul-ro 1203beon-gil, Baekseok-eup, Yangju-si Gyeonggi, South Korea, 11517
- Owner or operator
- JMT Co., Ltd. (10083217)
- Roles
- Manufacturer
- First device listed
- November 3, 2021
- Registered through
- 2026
- Brand names listed
- EDEN ControlCath, EDEN Peek Cage, EDEN Spinal Fixation MIS System, EDEN Spinal Fixation System, Osteo Cement Needle
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Conduction, Anesthetic | BSO | 2 | Manufacturer | accessdata.fda.gov |
| Injector, Vertebroplasty (Does Not Contain Cement) | OAR | 1 | Manufacturer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | 2 | Manufacturer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | 2 | Manufacturer | accessdata.fda.gov |
| Thoracolumbosacral Pedicle Screw System | NKB | 2 | 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 |
|---|---|---|---|---|---|---|
| February 13, 2025 | K241410 | EDEN ControlCath | BSO | Substantially Equivalent | Jmt Co., Ltd. | accessdata.fda.gov |
| June 15, 2023 | K230762 | EDEN Spinal Fixation MIS System | NKB | Substantially Equivalent | Jmt Co., Ltd. | accessdata.fda.gov |
| June 23, 2022 | K201788 | EDEN Spinal Fixation System | NKB | Substantially Equivalent | Jmt Co., Ltd. | accessdata.fda.gov |
| September 13, 2021 | K201793 | EDEN Peek Cage | ODP | Substantially Equivalent | Jmt Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter, Conduction, Anesthetic
- All makers of Injector, Vertebroplasty (Does Not Contain Cement)
- All makers of Thoracolumbosacral Pedicle Screw System
- All makers of Intervertebral Fusion Device With Bone Graft, Lumbar
- All makers of Intervertebral Fusion Device With Bone Graft, Cervical
Updated February 13, 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.