Showa Ika Kohgyo Co., Ltd.
Country not established
- Devices
- 2
What Showa Ika Kohgyo Co., Ltd. makes
Showa Ika Kohgyo Co., Ltd. manufactures the MYKRES Spinal System, a device designed for spinal surgical applications, including fixation and stabilization of the spine.
The MYKRES Spinal System is classified as a Class II medical device in the US and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Mykres Spinal System Ref K071074
Regimes: 510(k) Registry: 510(k)Mykres Spinal System Ref K051704
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Showa Ika Kohgyo Co., Ltd. have in the registry?
The registry currently lists 2 devices for Showa Ika Kohgyo Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Showa Ika Kohgyo Co., Ltd.'s devices?
Among its 2 most recently registered devices, Showa Ika Kohgyo Co., Ltd. has devices listed in FDA 510(k) (2 devices).
What risk classes do Showa Ika Kohgyo Co., Ltd.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Showa Ika Kohgyo Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Showa Ika Kohgyo Co., Ltd. in the registry?
The most recently registered devices listed for Showa Ika Kohgyo Co., Ltd. include MYKRES SPINAL SYSTEM.