Canary Medical USA LLC
Carlsbad, CA, US
CANARY MEDICAL USA LLC appears in FDA device records in Carlsbad, CA. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Canary Medical USA LLC carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Canary Medical, Inc.510(k), enforcement report, recall
510(k) clearance history
FDA records hold 4 510(k) clearances for Canary Medical USA LLC between 2021 and 2024. The busiest year on record is 2021, with 1. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K234056 | canturio® se (Canturio Smart Extension) | QPP | Substantially Equivalent | |
| K223803 | Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System | QPP | Substantially Equivalent | |
| K220413 | Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System | QPP | Substantially Equivalent | |
| DEN200064 | Canary Tibial Extension with Canary Health Implanted Reporting Processor (CHIRP) System | QPP | Unknown |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3015802419 | 3015802419 | CANARY MEDICAL USA LLC | 2710 Loker Ave. West, Suite 350, Carlsbad, CA 92010 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2099-2025 | Brand Name: Canturio Smart Extension Product Name: CSE Implant Model/Catalog Number: 43-5570-030-14 Product Description: Tibial stem extension for use with Zimmer Persona Personalized Knee System; 14mm diameter x 30mm height. Implantable device with integrated electronics for passive kinematic data collection. Single-use, sterile. Packaged in a sterile blister and outer shelf pack. Sold individually. Component: Yes. The Canturio Smart Extension (CSE) is a tibial implant component intended for use with the Zimmer Persona Personalized Knee System. | Due to labeling error. Product incorrectly labeled. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain