Beijing AK Medical Co., Ltd.
Registered establishment in Changping District, Beijing, China. 3 device types, 1 clearance.
Beijing AK Medical Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Plate, Fixation, Bone, Screw, Fixation, Bone and 1 other device type. Its earliest product listing with the FDA dates from 2018.
3device types registered with the FDA
1510(k) clearance
Registration
| Registered name | BEIJING AK MEDICAL CO, LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3013843055 |
| FEI number | 3013843055 |
| Establishment type | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
Chinese Registration
| Chinese legal name | 北京爱康宜诚医疗器材有限公司 |
|---|---|
| Source | export sales certificate, Beijing medical products administration |
Location
| City | Changping District |
|---|---|
| Province | Beijing |
| Address | No.5 Wen an Street |
| Postal code | 102299 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Plate, Fixation, Bone | Class 2 | Locking Plate System | 2024 | 22 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Class 2 | A3 Total Knee System | 2018 | 21 |
| Screw, Fixation, Bone | Class 2 | Locking Plate System | 2024 | 31 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K180493 | 2018-06-22 | JWH | Traditional | This company |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Core Technology Co., Ltd. | 14 |
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.