The following data is part of a premarket notification filed by Beijing Ak Medical Co., Ltd. with the FDA for A3 Total Knee System.
| Device ID | K180493 |
| 510k Number | K180493 |
| Device Name: | A3 Total Knee System |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | Beijing AK Medical Co., Ltd. No. 10 Baifuquan Road Beijing, CN 102200 |
| Contact | Aiguo Liu |
| Correspondent | Barry E Sands RQMIS, Inc. 110 Haverhill Road, Suite 526 Amesbury, MA 01913 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-26 |
| Decision Date | 2018-06-22 |
| Summary: | summary |