Clearance Summary
Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System received FDA 510(k) clearance under submission number K220413, sponsored by Canary Medical USA, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2022-06-22.
- Submission: K220413
- Applicant / Sponsor: Canary Medical USA, LLC
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3600
- Decision date: 2022-06-22
Classification & Regulation
This clearance is catalogued under FDA product code QPP and 21 CFR 888.3600, within the Orthopedic review panel as a Class II device.