510(k) DEN200064
DEN200064 is an FDA 510(k) premarket notification submitted by Canary Medical, Inc. for the device "Canary Tibial Extension with Canary Health Implanted Reporting Processor (CHIRP) System". The FDA issued a decision of De Novo Granted on August 27, 2021. The device falls under product code QPP (Implantable Post-Surgical Kinematic Measurement Knee Device), a Class II device regulated under 21 CFR 888.3600.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- August 27, 2021
- Date Received
- October 19, 2020
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Implantable Post-Surgical Kinematic Measurement Knee Device
- Device Class
- Class II
- Regulation Number
- 888.3600
- Review Panel
- OR
- Submission Type
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.