Data / Medical devices / China / Aike (shanghai) Medical Instrument Co., Ltd.
Aike (shanghai) Medical Instrument Co., Ltd.: FDA-registered device maker in Shanghai, China, 1 510(k) clearance
Aike (shanghai) Medical Instrument Co., Ltd. is registered with the FDA (registration 3018269629) in Shanghai, China. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 5, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3018269629
- Address
- Room F201, Floor2, Building 6, No.125, LongPan Road, Malu Town, Jiading District, 201801, Shanghai, China, Shanghai, China, 201801
- Owner or operator
- Aike (Shanghai) Medical Instrument Co., Ltd. (10080234)
- Roles
- Manufacturer
- First device listed
- January 20, 2021
- Registered through
- 2026
- Brand names listed
- AK-SET001, AK-SET002, AK-SET003, AK-SET004, AK-SET005, AK-SET006, AK-SET007, AK-SET008 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | 2 | Manufacturer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Manufacturer | accessdata.fda.gov |
| Pin, Fixation, Threaded | JDW | 2 | Manufacturer | accessdata.fda.gov |
| Tourniquet, Nonpneumatic | GAX | 1 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| January 5, 2021 | K200491 | Bfix Orthopedic External Fixator Systems | KTT | Substantially Equivalent | Aike (Shanghai) Medical Instrument Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Tourniquet, Nonpneumatic
- All makers of Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- All makers of Pin, Fixation, Threaded
- All makers of Orthopedic Manual Surgical Instrument
Updated January 5, 2021. 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.