FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System
K Number: K220413
·
Decision Jun 22, 2022
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
3
Applicant Total
3
Review Days
128
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System
- K Number
- K220413
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3600
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Canary Medical USA, LLC
- Date Received
- February 14, 2022
- Decision Date
- June 22, 2022
- Product Code
- QPP
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QPP | Implantable Post-Surgical Kinematic Measurement Knee Device | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QPP), ordered by most recent decision date.
canturio® se (Canturio Smart Extension)
FDA 510(k)
FDA Class 2
·Orthopedic
Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System
FDA 510(k)
FDA Class 2
·Orthopedic
Canary Tibial Extension with Canary Health Implanted Reporting Processor (CHIRP) System
FDA 510(k)
FDA Class 2
·Orthopedic