Seohancare Co., Ltd.
South KoreaFDA applicant, unverified
- Devices
- 1
What Seohancare Co., Ltd. makes
Seohancare Co., Ltd. manufactures the MEGAFIX® Pedicle Screw Spinal System, a spinal fixation device used for internal stabilization of the spine during surgical procedures.
The company’s spinal fixation system is classified as a Class II medical device in the US and is listed under the FDA’s 510(k) pathway. The manufacturer is based in the United States.
Catalogue
MEGAFIX® Pedicle Screw Spinal System Ref K191655
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Seohancare Co., Ltd. have in the registry?
The registry currently lists 1 device for Seohancare Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Seohancare Co., Ltd.'s devices?
Among its 1 most recently registered device, Seohancare Co., Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Seohancare Co., Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Seohancare Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Seohancare Co., Ltd. in the registry?
The most recently registered devices listed for Seohancare Co., Ltd. include MEGAFIX® Pedicle Screw Spinal System.