Sk Bioland Co., Ltd.
South KoreaFDA applicant, unverified
- Devices
- 1
What Sk Bioland Co., Ltd. makes
Sk Bioland Co., Ltd. manufactures the OssGuide, a medical device designed for surgical guidance in orthopedic procedures, specifically for bone grafting and fixation applications.
The OssGuide is classified as a Class II device under FDA regulations and is listed via the 510(k) pathway. The company is based in the United States.
Catalogue
OssGuide Ref K200623
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Sk Bioland Co., Ltd. have in the registry?
The registry currently lists 1 device for Sk Bioland Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sk Bioland Co., Ltd.'s devices?
Among its 1 most recently registered device, Sk Bioland Co., Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Sk Bioland Co., Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Sk Bioland Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sk Bioland Co., Ltd. in the registry?
The most recently registered devices listed for Sk Bioland Co., Ltd. include OssGuide.