Data / Medical devices / China / Arthrex Medical Device (Shanghai) Co. Ltd.
Arthrex Medical Device (Shanghai) Co. Ltd.: FDA-registered device maker in Shanghai, China, 1 510(k) clearance
Arthrex Medical Device (Shanghai) Co. Ltd. is registered with the FDA (registration 3031238646) in Shanghai, China. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 12, 2016. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3031238646
- Address
- Room C212, 2/F, West Sub-Building (Building C), Block 3, No. 88, Hedan Road, Pilot Free Trade Zone, Shanghai, China, 200131
- Owner or operator
- ARTHREX, INC. (1220287)
- Roles
- Exporter to the US
- First device listed
- August 7, 1996
- Registered through
- 2027
- Brand names listed
- Camera, Television, Surgical, Without Audio, INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Camera, Television, Surgical, Without Audio | FWB | 1 | Exporter to the US | accessdata.fda.gov |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | 1 | Exporter to the US | accessdata.fda.gov |
| Laparoscope, General & Plastic Surgery | GCJ | 2 | Exporter to the US | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 12, 2016 | K153218 | Arthrex Synergy UHD4 System | GCJ | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
- All makers of Laparoscope, General & Plastic Surgery
- All makers of Camera, Television, Surgical, Without Audio
Updated February 12, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.