Jmt Co., Ltd.
South KoreaFDA applicant, unverified FDA FEI 3021006165
- Devices
- 4
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Jmt Co., Ltd. makes
Jmt Co., Ltd. manufactures spinal fixation devices, including the EDEN ControlCath catheter, the EDEN Spinal Fixation Minimally Invasive System (MIS), the EDEN Spinal Fixation System, and the EDEN PEEK Cage for interbody fusion.
These products are classified as Class II medical devices and are listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
EDEN ControlCath Ref K241410
Regimes: 510(k) Registry: 510(k)EDEN Spinal Fixation MIS System Ref K230762
Regimes: 510(k) Registry: 510(k)EDEN Spinal Fixation System Ref K201788
Regimes: 510(k) Registry: 510(k)EDEN Peek Cage Ref K201793
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3021006165
- Address
- 70-39, Gwonyul-ro 1203beon-gil, Baekseok-eup, Yangju-si Gyeonggi
Frequently asked questions
How many devices does Jmt Co., Ltd. have in the registry?
The registry currently lists 4 devices for Jmt Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Jmt Co., Ltd.'s devices?
Among its 4 most recently registered devices, Jmt Co., Ltd. has devices listed in FDA 510(k) (4 devices).
What risk classes do Jmt Co., Ltd.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Jmt Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Jmt Co., Ltd. in the registry?
The most recently registered devices listed for Jmt Co., Ltd. include EDEN ControlCath, EDEN Spinal Fixation MIS System, EDEN Spinal Fixation System and EDEN Peek Cage.