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 |