FDA Registration
Active
🇰🇷 South Korea
ONSURGICAL CORP.
Reg #: 3011287176
·
FEI: 3011287176
·
Expires 2026
Products
6
Proprietary Names
15
Establishment Types
2
Classifications
6
Registration Details
- Registration Name
- ONSURGICAL CORP.
- Registration Number
- 3011287176
- FEI Number
- 3011287176
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- F1013 Misa Centum Biz, 45, Jojeong-daero, Hanam-si, Gyeonggi-do
- City
- Seoul
- Country
- KR
Owner / Operator
- Firm Name
- Onsurgical Corp.
- Operator Number
- 10048066
- Address
- 207, Hyundai Shopping Complex 434-2, Junggye-dong, Nowon-ku
- City
- Seoul
- State
- KR-11
- Postal Code
- 139-859
- Country
- KR
- Correspondent
- Nic Lim
US Agent
- Business Name
- ST&G USA Corporation
- Contact Name
- Glenn Choi
- Address
- 2691 Saturn St
- City
- Brea
- State
- CA
- ZIP
- 92821
- Country
- US
- [email protected]
- Phone
- 714 5240663
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bandage, Cast | ITG | Class 1 | Physical Medicine | No | 2021-02-23 |
| Joint, Knee, External Limb Component | ISY | Class 1 | Physical Medicine | No | 2016-05-25 |
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 2016-05-25 |
| Device, Prosthesis Alignment | IQO | Class 1 | Physical Medicine | No | 2016-07-19 |
| Component, External, Limb, Ankle/Foot | ISH | Class 1 | Physical Medicine | No | 2019-12-10 |
| Orthosis, Lumbar | IQE | Class 1 | Physical Medicine | No | 2014-12-03 |
Proprietary Names
Bandage, cast
3040 MAG Liner Premier BK
3020L Parasil Locking Liner BK
3060 MAG Liner Premier AK
3070L Parasil Locking Liner AK
Knee Jack OA Brace
3201 XP valve
3010L forte liner
EXTERNAL LIMB, ANKLE/FOOT
LS-627B Balboa Comfort LSO Brace sizes 2X 4X
LS-637A Avalon Contour LSO Brace sizes XS XL
LS-627A Balboa Comfort LSO Brace sizes XS XL
LS-637B Avalon Contour LSO Brace sizes 2X 4X
LS-631B Capri Comfort LSO Brace - sizes 2X - 4X
LS-631A Capri Comfort LSO Brace - sizes XS - XL
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device