DEN200064 is an FDA 510(k) submission for the Canary Tibial Extension with Canary Health Implanted Reporting Processor (CHIRP) System. This device is classified as a Implantable Post-surgical Kinematic Measurement Knee Device (Class II - Special Controls, product code QPP).
Submitted by Canary Medical, Inc. (Vancouver, CA). The FDA issued a Not Cleared (DENG) decision on August 27, 2021.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3600. An Implantable Post-surgical Kinematic Measurement Knee Device Is A Device That Provides Objective Kinematic Data After Total Knee Arthroplasty Surgery. The Kinematic Data Provided By The Device Are Used As An Adjunct To Other Physiological Parameter Measurement Tools Utilized During The Course Of Patient Monitoring And Treatment Post-surgery..
| 510(k) Number | DEN200064 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | October 19, 2020 |
| Decision Date | August 27, 2021 |
| Days to Decision | 312 days |
| Submission Type | Direct |
| Review Panel | Orthopedic (OR) |
| Summary | - |
| Product Code | QPP - Implantable Post-surgical Kinematic Measurement Knee Device |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3600 |
| Definition | An Implantable Post-surgical Kinematic Measurement Knee Device Is A Device That Provides Objective Kinematic Data After Total Knee Arthroplasty Surgery. The Kinematic Data Provided By The Device Are Used As An Adjunct To Other Physiological Parameter Measurement Tools Utilized During The Course Of Patient Monitoring And Treatment Post-surgery. |