FDA Registration
Active
🇨🇳 China
SUZHOU MICROPORT ORTHORECON CO., LTD.
Reg #: 3014662844
·
FEI: 3014662844
·
Expires 2026
Products
31
Proprietary Names
1
Establishment Types
4
Classifications
31
Registration Details
- Registration Name
- SUZHOU MICROPORT ORTHORECON CO., LTD.
- Registration Number
- 3014662844
- FEI Number
- 3014662844
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Building 2 and 3,N0.151,Fengli Street,Suzhou Industrial Park, China (Jiangsu) Pilot Free Trade Zone Suzhou District
- City
- Suzhou Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K244039
Owner / Operator
- Firm Name
- Suzhou MicroPort OrthoRecon Co., Ltd.
- Operator Number
- 10060911
- Address
- Building 2 and 3,N0.151,Fengli Street,Suzhou Industrial Park, China (Jiangsu) Pilot Free Trade Zone Suzhou District
- City
- Suzhou
- State
- Jiangsu
- Postal Code
- 215000
- Country
- CN
- Correspondent
- YuJian Mao
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2019-07-11 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2019-07-11 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2019-07-11 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2024-08-01 |
| Caliper | KTZ | Class 1 | Orthopedic | No | 2019-07-11 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2024-08-01 |
| Probe | HXB | Class 1 | Orthopedic | No | 2019-07-11 |
| Pusher, Socket | HXO | Class 1 | Orthopedic | No | 2019-07-11 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 2024-08-01 |
| Positioner, Socket | KIL | Class 1 | Orthopedic | No | 2019-07-12 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2019-07-11 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2019-07-11 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2024-08-01 |
| Driver, Prosthesis | HWR | Class 1 | Orthopedic | No | 2024-08-01 |
| Broach | HTQ | Class 1 | Orthopedic | No | 2024-08-01 |
| Template | HWT | Class 1 | Orthopedic | No | 2019-07-11 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2019-07-11 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2019-07-11 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2019-07-11 |
| Punch, Surgical | LRY | Class 1 | General, Plastic Surgery | No | 2019-07-11 |
| Rasp, Surgical, General & Plastic Surgery | GAC | Class 1 | General, Plastic Surgery | No | 2024-08-01 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2024-08-01 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2019-07-11 |
| Hammer, Surgical | FZY | Class 1 | General, Plastic Surgery | No | 2019-07-11 |
| Osteotome | HWM | Class 1 | General, Plastic Surgery | No | 2019-07-11 |
| Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | HRY | Class 2 | Orthopedic | No | 2025-03-23 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2025-03-23 |
| Punch, Femoral Neck | HWP | Class 1 | Orthopedic | No | 2024-08-01 |
| Bit, Surgical | GFG | Class 1 | General, Plastic Surgery | No | 2024-08-01 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2024-08-01 |
| Holder, Needle; Orthopedic | HXK | Class 1 | Orthopedic | No | 2019-07-12 |
Proprietary Names
EVOLUTION MPX
Establishment Types
Repack or Relabel Medical Device
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device