The following data is part of a De Novo classification by Canary Medical, Inc. with the FDA for Canary Tibial Extension With Canary Health Implanted Reporting Processor (chirp) System.
| DeNovo ID | DEN200064 |
| Device Name: | Canary Tibial Extension With Canary Health Implanted Reporting Processor (CHIRP) System |
| Classification | Implantable Post-surgical Kinematic Measurement Knee Device |
| Applicant | Canary Medical, Inc. 2150 Western Parkway, Suite 202 Vancouver, CA V6t 1v6 |
| Contact | Nora C.r. York |
| Product Code | QPP |
| CFR Regulation Number | 888.3600 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(De Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | Orthopedic |
| Classification Advisory | Orthopedic |
| Type | Direct |
| Date Received | 2020-10-19 |
| Decision Date | 2021-08-27 |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860003118351 | DEN200064 | 000 |
| 00850015699023 | DEN200064 | 000 |
| 00850015699030 | DEN200064 | 000 |
| 00850015699047 | DEN200064 | 000 |
| 00850015699054 | DEN200064 | 000 |
| 00850015699061 | DEN200064 | 000 |
| 00850015699078 | DEN200064 | 000 |
| 00850015699085 | DEN200064 | 000 |
| 00850015699092 | DEN200064 | 000 |
| 00850015699108 | DEN200064 | 000 |
| 00860003118306 | DEN200064 | 000 |
| 00850015699009 | DEN200064 | 000 |