510(k) DEN200064
- Device
- Canary Tibial Extension with Canary Health Implanted Reporting Processor (CHIRP) System
- Applicant
- Canary Medical, Inc.
- 510(k) number
- DEN200064
- Product code
- QPP
- Decision
- Unknown (DENG)
- Decision date
- 2021-08-27
- Date received
- 2020-10-19
- Regulation
- 888.3600
- Classification name
- Implantable Post-Surgical Kinematic Measurement Knee Device
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Nora C.R. York
- Address
- 2150 Western Pkwy., Suite 202 Vancouver CA V6T 1V6 V6T 1V6
FDA Registration Numbers#
- 1828288
- 3015802419
- 3024996452
- 3013368220
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code QPP#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K234056 | canturio® se (Canturio Smart Extension) | Canary Medical USA, LLC | 2024-04-24 |
| 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 |