The following data is part of a premarket notification filed by Kico Knee Innovation Company Pty Limited with the FDA for 360ks Implant Positioning System.
| Device ID | K163405 |
| 510k Number | K163405 |
| Device Name: | 360KS Implant Positioning System |
| Classification | System, Image Processing, Radiological |
| Applicant | Kico Knee Innovation Company PTY Limited Suite 3, Building 1, 20 Bridge Street Pymble, AU 2073 |
| Contact | Karl Rentsch |
| Correspondent | Sandy Hedberg SoftwareCPR 448 Mariner Point Drive Clinton, TN 37716 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-05 |
| Decision Date | 2017-03-21 |
| Summary: | summary |