OSTEONIC CO., Ltd.
Active in EUDAMEDSouth Koreafrom SRN EUDAMED FDA SRN KR-MF-000008969 FEI 3011530718
- Devices
- 1,959
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI
- Authorised rep.
- Emergo Europe B.V.NL
What OSTEONIC CO., Ltd. makes
Osteonic Co., Ltd. makes orthopaedic devices such as bone screws, fixation plates, and tendon/ligament bone anchors, as well as reusable instruments like surgical drill guides, screwdrivers, and instrument trays. They also produce cranioplasty plates.
The company's portfolio includes devices classified as Class I and Class II, and is listed in the FDA UDI registry. Osteonic Co., Ltd. is based in South Korea.
Catalogue
Search and filter all 1,959 devicesShowing 1-50 of 1,959
Company details
- EUDAMED SRN
- KR-MF-000008969
- FDA FEI number
- 3011530718
- DUNS number
- 688999370
- EUDAMED status
- Active since 2023
- EUDAMED registered name
- OSTEONIC Co., Ltd.
- Registered address
- 405Ho, 505-2Ho, 505-3Ho, 508Ho, 603Ho, 706Ho, 902Ho, 1002Ho, 1004Ho, 1005Ho, 1103Ho, 12F, 38, Digital-ro 29-gil, Guro-gu, and 102Ho, 103Ho, 105Ho, 24, Digital-ro 27-gil, Guro-gu, 1012Ho, 1013Ho, 272, Digital-ro, Guro-gu, and 102Ho, 103Ho, 104-1Ho, 104-2Ho, 105Ho, 106Ho, 36, Digital-ro 27 gil, Guro-gu, 08381, Seoul, South Korea
- jisun@osteonic.com
- Phone
- +82269028411
- PRRC contact
- Chang ho Moon
Frequently asked questions
How many devices does OSTEONIC CO., Ltd. have in the registry?
The registry currently lists 1959 devices for OSTEONIC CO., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list OSTEONIC CO., Ltd.'s devices?
Among its 50 most recently registered devices, OSTEONIC CO., Ltd. has devices listed in EUDAMED (50 devices).
What risk classes do OSTEONIC CO., Ltd.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for OSTEONIC CO., Ltd.'s devices are Class I, Class IIb and Class III. Each device page shows its own class and authorisation.
What are the newest devices from OSTEONIC CO., Ltd. in the registry?
The most recently registered devices listed for OSTEONIC CO., Ltd. include BMA-4518-BC20, BSA-2110-DR, BMA-4518-BC21 and BMA-4518-BC30.