FDA Registration
Active
🇰🇷 South Korea
Y7F.35020
Reg #: 3011530718
·
FEI: 3011530718
·
Expires 2025
Products
1
Proprietary Names
60
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 |
|---|---|---|---|---|---|
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2021-07-19 |
Proprietary Names
Y7F.35020
Y1Z8030
Y1F.35040
Y1Z.28020
Y1F.35020
375PKT
Y1F.35070
C8P4020
Y1Z.14010
B1P203
C8P2070
B1P702
A8201
Y7Z0070
C8P2080
Y1F.45020
Y1Z.16010
B1P204
Y7F.35010
C8P4030
Y7Z.40010
Y1Z.11010
Y7Z.45010
Y1Z.35030
Y7Z0050
Y7Z0030
C8P2030
Y1C.28010
Genie Labral Instruments
110045295
Y1F.50020
B1P703
C8P1010
Y7D.15010
D8P4110
Y1C.35020
Y1F.50010
B1P701
Y1D.50020
Y1F.35030
A8202
C8P2090
Y1F.28030
D8P2010
Y1F.28010
Y1A.25010
Y1F.28040
BIS-04225-DG
Y1Z.25010
Y1D.35010
Y7Z0040
Y1F.35010
D8P4080
A8901
C8P2010
Y7F.50010
Y1F.45030
A8902
Y7Z0060
Y7F.50020
Establishment Types
Manufacture Medical Device