The following data is part of a premarket notification filed by L And K Biomed Corporation Limited with the FDA for Ask System.
| Device ID | K181146 |
| 510k Number | K181146 |
| Device Name: | ASK System |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | L And K Biomed Corporation Limited 18f, 159-1, Mokdongseo-ro Yangcheon-gu, KR 07997 |
| Contact | Semi Jang |
| Correspondent | Semi Jang L And K Biomed Corporation Limited 18f, 159-1, Mokdongseo-ro Yangcheon-gu, KR 07997 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-01 |
| Decision Date | 2018-08-03 |
| Summary: | summary |