Arthrex Medical Device (Shanghai) Co., Ltd.
Registered establishment in Shanghai, China. 3 device types.
Arthrex Medical Device (Shanghai) Co., Ltd. is an exporter holding a current FDA establishment registration. The registration covers Laparoscope, General & Plastic Surgery, Camera, Television, Surgical, Without Audio and 1 other device type. Its earliest product listing with the FDA dates from 1996.
Registration
| Registered name | Arthrex Medical Device (Shanghai) Co. Ltd. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3031238646 |
| FEI number | 3031238646 |
| Establishment type | Exporter |
Location
| City | Shanghai |
|---|---|
| Province | Shanghai |
| Address | Room C212, 2/F, West Sub-Building (Building C), Block 3, No. 88, Hedan Road, Pilot Free Trade Zone |
| Postal code | 200131 |
| Country | China |
Group
Arthrex Medical Device (Shanghai) Co., Ltd. is one of 2 plants registered under ARTHREX, INC..
| Plant | City | Device types |
|---|---|---|
| Arthrex (Shanghai) Co., Ltd. | Shanghai | 38 |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Camera, Television, Surgical, Without Audio | Class 1 | Camera, Television, Surgical, Without Audio | 2024 | 5 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | Class 1 | Instrument, Surgical, Orthopedic, AC-Powered Motor AND Accessory/Attachment | 1996 | 23 |
| Laparoscope, General & Plastic Surgery | Class 2 | 2016 | 46 |
Clearances
No clearance names Arthrex Medical Device (Shanghai) Co., Ltd. as applicant. One is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K153218 | 2016-02-12 | GCJ | Traditional | Arthrex, Inc. |
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.