FDA Registration
Active
🇨🇳 China
SUZHOU ENDOPHIX CO., LTD.
Reg #: 3030514683
·
FEI: 3030514683
·
Expires 2026
Products
17
Proprietary Names
14
Establishment Types
1
Classifications
17
Registration Details
- Registration Name
- SUZHOU ENDOPHIX CO., LTD.
- Registration Number
- 3030514683
- FEI Number
- 3030514683
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Room 202, Factory No.3, Lane 151, Fengli Road, SIP, 215000 Suzhou, Jiangsu Province, P.R. CHINA
- City
- Suzhou Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K230874
Owner / Operator
- Firm Name
- Suzhou Endophix Co., Ltd.
- Operator Number
- 10089613
- Address
- Lane 151, Fengli Road, SIP, 215000 Suzhou, Jiangsu Province, P.R. CHINA
- City
- Suzhou
- State
- Jiangsu
- Postal Code
- 215000
- Country
- CN
- Correspondent
- Bin Wu
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Positioner, Socket | KIL | Class 1 | Orthopedic | No | 2023-12-22 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2023-12-22 |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2023-12-22 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2023-12-22 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2023-12-22 |
| Passer, Wire, Orthopedic | HXI | Class 1 | Orthopedic | No | 2023-12-22 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2023-12-22 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2023-12-22 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2023-12-22 |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | Class 1 | General, Plastic Surgery | No | 2023-12-22 |
| Probe | HXB | Class 1 | Orthopedic | No | 2023-12-22 |
| Knife, Orthopedic | HTS | Class 1 | Orthopedic | No | 2023-12-22 |
| File | HTP | Class 1 | Orthopedic | No | 2023-12-22 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2023-12-22 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2023-12-22 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2024-05-09 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2023-12-22 |
Proprietary Names
Knee Surgery Instrument, Shoulder Surgery Instrument
Syntheface PEEK Interference Screw, Syntheface PEEK Screw Sheath
Arthroscopic cannula
Drill & Guide, Knee Surgery Instrument, Shoulder Surgery Instrument
Orthopedic Passer Instrument, Shoulder Surgery Instrument
Knee Surgery Instrument
Orthopedic Surgical Instrument, Shoulder Surgery Instrument
Single-use Shaver Blade
Graft Preparation Platform Set, Knee Surgery Instrument, Shoulder Surgery Instrument, Tissue Suture Passer
Rotator Cuff Repair Instrument, Shoulder Surgery Instrument
Megaloop Button System
Javelot PK-P suture anchor (Knotless), Javelot PK-L suture anchor (Knotless)
Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture anchor
Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor
Establishment Types
Manufacture Medical Device