The following data is part of a premarket notification filed by Rootloc Co., Ltd. with the FDA for Acculoc Total Knee System.
| Device ID | K170753 |
| 510k Number | K170753 |
| Device Name: | Acculoc Total Knee System |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | RootLoc Co., Ltd. #1210, 68, Digital-ro 9-gil Geumcheon-gu, KR 08512 |
| Contact | Jungsun Ha |
| Correspondent | Jungsun Ha RootLoc Co., Ltd. #1210, 68, Digital-ro 9-gil Geumcheon-gu, KR 08512 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-13 |
| Decision Date | 2018-03-23 |
| Summary: | summary |