The following data is part of a premarket notification filed by K1 Medical Llc with the FDA for Ez-trax Stryker Mako Total Knee With Triathlon Containment Device.
| Device ID | K202270 |
| 510k Number | K202270 |
| Device Name: | EZ-TRAX Stryker Mako Total Knee With Triathlon Containment Device |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | K1 Medical LLC 56 Newton Road Woodbridge, CT 06525 |
| Contact | Jospeh Azary |
| Correspondent | Joseph Azary Joseph Azary 543 Long Hill Avenue Shelton, CT 06484 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-11 |
| Decision Date | 2020-12-02 |