Suzhou Microport Orthorecon Co., Ltd.
Registered establishment in Suzhou, Jiangsu, China. 31 device types, 1 clearance.
Suzhou Microport Orthorecon Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Clamp, Probe and 29 other device types. Its earliest product listing with the FDA dates from 2019.
31device types registered with the FDA
1510(k) clearance
Registration
| Registered name | SUZHOU MICROPORT ORTHORECON CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3014662844 |
| FEI number | 3014662844 |
| Establishment type | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
Location
| City | Suzhou |
|---|---|
| Province | Jiangsu |
| Address | Building 2 and 3,N0.151,Fengli Street,Suzhou Industrial Park |
| Postal code | 215000 |
| Country | China |
What It Makes
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K244039 | 2025-02-28 | JWH | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1998 |
|---|---|
| Factory area | 170000 square meters (Suzhou location) |
| Main products | Hip replacement systems, Knee replacement systems, Spinal implants, SkyWalker Surgical Robot, Orthopedic trauma products |
| Certifications | FDA, CE |
| Export markets | 70 countries worldwide |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.