The following data is part of a premarket notification filed by Hangzhou Lancet Robotics Co., Ltd. with the FDA for Robpath® Total Hip Application.
| Device ID | K220774 |
| 510k Number | K220774 |
| Device Name: | RobPath® Total Hip Application |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Hangzhou Lancet Robotics Co., Ltd. 508, 5th Floor, Building 4, No. 5, Lvtai Road, Zhongtai Street, Yuhang District Hangzhou, CN 311100 |
| Contact | Rennes Zhang |
| Correspondent | Gordon Shu Shanghai Zhirui Management Consulting Co., Ltd. No. 741 Yao Zhou Road, Xin Cun, Chong Ming District Shanghai, CN 202150 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-16 |
| Decision Date | 2022-12-09 |