FDA Registration
Active
🇯🇵 Japan
KSI CO., LTD.
Reg #: 3016032497
·
FEI: 3016032497
·
Expires 2026
Products
27
Proprietary Names
0
Establishment Types
1
Classifications
27
Registration Details
- Registration Name
- KSI CO., LTD.
- Registration Number
- 3016032497
- FEI Number
- 3016032497
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 734-5, Itazuma
- City
- Gotemba Shizuoka
- Country
- JP
Owner / Operator
- Firm Name
- KSI Co., Ltd.
- Operator Number
- 10090080
- Address
- 734-5, Itazuma
- City
- Gotemba
- State
- Shizuoka
- Postal Code
- 4120048
- Country
- JP
US Agent
- Business Name
- GLOBIZZ CORPORATION
- Contact Name
- Takahiro Haruyama
- Address
- 970 W 190th St Ste 200
- City
- Torrance
- State
- CA
- ZIP
- 90502
- Country
- US
- [email protected]
- Phone
- 310 5383860
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2024-02-16 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2024-02-16 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2024-02-20 |
| Blade, Scalpel | GES | Class 1 | General, Plastic Surgery | No | 2024-02-20 |
| Curette, Surgical, General Use | FZS | Class 1 | General, Plastic Surgery | No | 2024-02-16 |
| Template | HWT | Class 1 | Orthopedic | No | 2024-05-21 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2024-02-20 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2024-02-20 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2024-02-20 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2026-06-18 |
| Osteotome | HWM | Class 1 | General, Plastic Surgery | No | 2024-02-20 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2024-02-13 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2024-09-11 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2026-02-17 |
| Probe | HXB | Class 1 | Orthopedic | No | 2024-02-20 |
| Tamp | HXG | Class 1 | Orthopedic | No | 2026-02-17 |
| Rongeur | HTX | Class 1 | Orthopedic | No | 2026-03-06 |
| Instrument, Compression | HWN | Class 1 | Orthopedic | No | 2024-02-20 |
| Guide, Needle, Surgical | GDF | Class 1 | General, Plastic Surgery | No | 2024-02-16 |
| Instrument, Bending Or Contouring | HXP | Class 1 | Orthopedic | No | 2026-02-17 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2024-02-16 |
| Bender | HXW | Class 1 | Orthopedic | No | 2024-02-20 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2024-02-20 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2024-02-20 |
| Cutter, Surgical | FZT | Class 1 | General, Plastic Surgery | No | 2024-02-16 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2024-09-12 |
| Elevator | HTE | Class 1 | General, Plastic Surgery | No | 2025-11-26 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)