FDA Registration
Active
🇰🇷 South Korea
Y1B.35010
Reg #: 3011530718
·
FEI: 3011530718
·
Expires 2025
Products
1
Proprietary Names
55
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- OSTEONIC CO., LTD.
- Registration Number
- 3011530718
- FEI Number
- 3011530718
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 405,505-2,505-3,508,603,902,1004,1005,1103,1201,1202,1203,1204,1205,1206-Ho, 38, Digital-ro 29-gil, Guro-gu, 102, 103-Ho, 24, Digital-ro 27-gil, Guro-gu, 1012, 1013-Ho, 272, Digital-ro, Guro-gu
- City
- Seoul
- Country
- KR
Owner / Operator
- Firm Name
- OSTEONIC Co., Ltd.
- Operator Number
- 10048673
- Address
- 1004Ho,1206Ho,38, Digital-ro 29-gil, Guro-gu, 102Ho, 103Ho, 24, Digital-ro 27-gil, Guro-gu
- City
- Seoul
- State
- KR-NOTA
- Postal Code
- 08381
- Country
- KR
- Correspondent
- Dong Won Lee
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2015-03-03 |
Proprietary Names
Y1B.35010
C8P.22040
Y7D.35010
Y1B.50020
Y1D.50010
Optimus CMF System - Screw driver (various models)
Optimus CMF System - Screw driver body (various models)
FDS-05
ODS-03
IDS-01
IOC-012
ODS-01
MDS-02
FDS-03
IOC-018
ACL-0329-DRIVER-1
ODS-04
PIS-0430-DRIVER
IOC-010
IDS-02
IOC-013
IDS-03
MDS-01
MDS-03
IOC-017
FDS-01
B1P.2301
FDS-02
D8P.22020
C8P.26060
C8P.26050
C8P.22050W
C8P.22040R
C8P.26040
A8104
Y1B.28010
C8P.22060R
IOC-011
FDS-04
ODS-02
Y1B.35020
D8P.22010
Y7D4010
Y7B.35010
A8103
110045321
110045320
Y7B.25010
C8P.22030
Y7D.25010
C8P.22050R
C8P.22060W
A8102
Y1B.28011
Y1B.50030
Establishment Types
Manufacture Medical Device