Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System
FDA 510(k) clearance K223803 · decided 2023-03-24
Clearance details
- K-number
- K223803
- Device name
- Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System
- Applicant
- Canary Medical USA, LLC
- Decision
- Substantially Equivalent
- Date received
- 2022-12-19
- Decision date
- 2023-03-24
- Days to decision
- 95 days
- Clearance type
- Traditional
- Product code
- QPP
- Device class
- 2
- Regulation number
- 888.3600
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Carlsbad, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| canturio® se (Canturio Smart Extension) (K234056) | Canary Medical USA, LLC | 2024-04-24 |
| Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System (K220413) | Canary Medical USA, LLC | 2022-06-22 |
| Canary Tibial Extension with Canary Health Implanted Reporting Processor (CHIRP) System (DEN200064) | Canary Medical, Inc. | 2021-08-27 |
Recalls involving this device
No recalls on record reference this clearance.