FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System
K Number: K223803
·
Decision Mar 24, 2023
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
3
Applicant Total
3
Review Days
95
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Basic Information
- Device Name
- Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System
- K Number
- K223803
- 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
- December 19, 2022
- Decision Date
- March 24, 2023
- 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 |
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