510(k) K223803
K223803 is an FDA 510(k) premarket notification submitted by Canary Medical USA, LLC for the device "Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System". The FDA issued a decision of Substantially Equivalent on March 24, 2023. The device falls under product code QPP (Implantable Post-Surgical Kinematic Measurement Knee Device), a Class II device regulated under 21 CFR 888.3600. Canary Medical USA, LLC has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 24, 2023
- Date Received
- December 19, 2022
- Clearance Type
- Traditional
- 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.