Data / Medical devices / China / Beijing Ak Medical Co, Ltd
Beijing Ak Medical Co, Ltd: FDA-registered device maker in Changping District Beijing, China, 1 510(k) clearance
Beijing Ak Medical Co, Ltd is registered with the FDA (registration 3013843055) in Changping District Beijing, China. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 22, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013843055
- Address
- No.5 Wen an Street, Changping District Beijing, China, 102299
- Owner or operator
- Beijing AK Medical Co, Ltd (10059173)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer
- First device listed
- December 12, 2018
- Registered through
- 2026
- Brand names listed
- A3 Total Knee System, Locking Plate System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Plate, Fixation, Bone | HRS | 2 | Contract manufacturer | accessdata.fda.gov |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Contract 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 |
|---|---|---|---|---|---|---|
| June 22, 2018 | K180493 | A3 Total Knee System | JWH | Substantially Equivalent | Beijing AK Medical Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Screw, Fixation, Bone
- All makers of Plate, Fixation, Bone
- All makers of Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Updated June 22, 2018. 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.