The following data is part of a premarket notification filed by Canary Medical Usa Llc with the FDA for Canary Tibial Extension (cte) With Canary Health Implanted Reporting Processor (chirp) System.
| Device ID | K220413 |
| 510k Number | K220413 |
| Device Name: | Canary Tibial Extension (CTE) With Canary Health Implanted Reporting Processor (CHIRP) System |
| Classification | Implantable Post-surgical Kinematic Measurement Knee Device |
| Applicant | Canary Medical USA LLC 2710 Loker Ave. West, Suite 350 Carlsbad, CA 92010 |
| Contact | Nora C.R. York |
| Correspondent | Nora C.R. York Canary Medical USA LLC 2710 Loker Ave. West, Suite 350 Carlsbad, CA 92010 |
| Product Code | QPP |
| CFR Regulation Number | 888.3600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-14 |
| Decision Date | 2022-06-22 |