FDA Registration
Active
🇰🇷 South Korea
Z1M3020
Reg #: 3011530718
·
FEI: 3011530718
·
Expires 2025
Products
1
Proprietary Names
85
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 |
|---|---|---|---|---|---|
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2015-03-03 |
Proprietary Names
Z1M3020
Z1Y1220
Z1C2010
Z1C.50010
Z1Z.50010
Z1Z1040
Z1B1010
Z1M3010
Z1B1010-ACE
Z1M.35010
Z1Y3010
Z1F3010
Z1Z1010
Z1Z1030
Z1Y1310
Z1B2010
C9Q1010
Z1M.50010
Z1Y1210
Z1Y1410
D9Q1020
B1Q101
Z1B.50010-AC
Z1F.50010
Z1Z1020
Z1C.20010
Z1M1010
Z1Z1050
Z1Y1110
Z1B2010-ACE
Z1Z3010
Z1B3010-AC
Z1Z2010
Z1C3010
Tray (various models)
TPF-002
TPF-003
TPO-003
PHL-001
TIN-006
TSM-003
TPM-004
TCM-002
TPN-002
TCP-002
TPN-003
TPO-001
PSK-001
TPM-001
PLL-001
TPM-002
TPN-005
GIN-006
TPN-001
TCP-001
TPO-002
MFK-001
TSM-001
Z1B3010
TSN-001
TSM-002
TPM-003
Z1Y1320
Z1C1010
Y1L3020
Z1Y.50010
Z1F1010
Z1A.50010
Z1Y1120
A9101
Z1F2010
TSF-001
Z1A3010
TSO-001
TPF-001
TCM-001
TSM-004
TCN-001
Z1A1010
Z1B.50010
Z1Y2010
Z1M.50020
TPN-007
Z1A2010
Y1L3010
Establishment Types
Manufacture Medical Device