510(k) K234056
- Device
- canturio® se (Canturio Smart Extension)
- Applicant
- Canary Medical USA, LLC
- 510(k) number
- K234056
- Product code
- QPP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-04-24
- Date received
- 2023-12-22
- Regulation
- 888.3600
- Classification name
- Implantable Post-Surgical Kinematic Measurement Knee Device
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Kevin Leung
- Address
- 2710 Loker Ave. W., Suite 350 Carlsbad CA US 92010 92010
FDA Registration Numbers#
- 1828288
- 3015802419
- 3024996452
- 3013368220
Source Documents#
Other 510(k) Records For Product Code QPP#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K223803 | Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System | Canary Medical USA, LLC | 2023-03-24 |
| K220413 | Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System | Canary Medical USA, LLC | 2022-06-22 |
| DEN200064 | Canary Tibial Extension with Canary Health Implanted Reporting Processor (CHIRP) System | Canary Medical, Inc. | 2021-08-27 |