Kyung Won Medical Co., Ltd.
Country not established
- Devices
- 4
What Kyung Won Medical Co., Ltd. makes
Kyung Won Medical Co., Ltd. manufactures resorbable bone graft substitutes, including POLYBONE Granule & Block for orthopedic applications, POLYBONE for general bone regeneration, and POLYBONE Dental for dental bone grafting. The company also produces the TYCHE Pedicle Screw System, a fixation device for spinal stabilization.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company operates from the United States.
Catalogue
Polybone Granule & Block Ref K082338
Regimes: 510(k) Registry: 510(k)Polybone Ref K070012
Regimes: 510(k) Registry: 510(k)Polybone Dental Ref K092194
Regimes: 510(k) Registry: 510(k)Tyche Pedicle Screw System Ref K100373
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Kyung Won Medical Co., Ltd. have in the registry?
The registry currently lists 4 devices for Kyung Won Medical Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Kyung Won Medical Co., Ltd.'s devices?
Among its 4 most recently registered devices, Kyung Won Medical Co., Ltd. has devices listed in FDA 510(k) (4 devices).
What risk classes do Kyung Won Medical Co., Ltd.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Kyung Won Medical Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Kyung Won Medical Co., Ltd. in the registry?
The most recently registered devices listed for Kyung Won Medical Co., Ltd. include POLYBONE GRANULE & BLOCK, POLYBONE, POLYBONE DENTAL and TYCHE PEDICLE SCREW SYSTEM.