canturio® se (Canturio Smart Extension)
FDA 510(k) clearance K234056 · decided 2024-04-24
Clearance details
- K-number
- K234056
- Device name
- canturio® se (Canturio Smart Extension)
- Applicant
- Canary Medical USA, LLC
- Decision
- Substantially Equivalent
- Date received
- 2023-12-22
- Decision date
- 2024-04-24
- Days to decision
- 124 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 |
|---|---|---|
| Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System (K223803) | Canary Medical USA, LLC | 2023-03-24 |
| 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
| Record | Firm | Date |
|---|---|---|
| Brand Name: Canturio Smart Extension Product Name: CSE Implant Model/Catalog Number: 43-55 recall (Z-2099-2025) | Canary Medical, Inc. | 2025-07-08 |