canturio™te Provisional

GUDID 00860003118351

The Persona Tibial Keel length ranges from 23.4 mm to 40 mm. The Canary Medical Tibial Extension adds 58 mm to the length of the tibial keel nominally when assembled. This CTE Provisional is used to ensure the fit of the CTE implant within the patient’s anatomy prior to CTE implantation.

Canary Medical USA LLC

Knee tibia prosthesis trial

• Primary Device ID: 00860003118351
• NIH Device Record Key: f0d2e6d1-ba27-443f-84e9-a69118556264
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: canturio™te Provisional
• Version Model Number: 43-5571-058-14
• Company DUNS: 117153396
• Company Name: Canary Medical USA LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860003118351 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN200064

FDA Product Code

• QPP: Implantable Post-Surgical Kinematic Measurement Knee Device

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00860003118351]

Moist Heat or Steam Sterilization

[00860003118351]

Moist Heat or Steam Sterilization

[00860003118351]

Moist Heat or Steam Sterilization

[00860003118351]

Moist Heat or Steam Sterilization

[00860003118351]

Moist Heat or Steam Sterilization

[00860003118351]

Moist Heat or Steam Sterilization

[00860003118351]

Moist Heat or Steam Sterilization

[00860003118351]

Moist Heat or Steam Sterilization

[00860003118351]

Moist Heat or Steam Sterilization

[00860003118351]

Moist Heat or Steam Sterilization

[00860003118351]

Moist Heat or Steam Sterilization

[00860003118351]

Moist Heat or Steam Sterilization

[00860003118351]

Moist Heat or Steam Sterilization

[00860003118351]

Moist Heat or Steam Sterilization

[00860003118351]

Moist Heat or Steam Sterilization

[00860003118351]

Moist Heat or Steam Sterilization

[00860003118351]

Moist Heat or Steam Sterilization

[00860003118351]

Moist Heat or Steam Sterilization

[00860003118351]

Moist Heat or Steam Sterilization

[00860003118351]

Moist Heat or Steam Sterilization

[00860003118351]

Moist Heat or Steam Sterilization

[00860003118351]

Moist Heat or Steam Sterilization

[00860003118351]

Moist Heat or Steam Sterilization

[00860003118351]

Moist Heat or Steam Sterilization

[00860003118351]

Moist Heat or Steam Sterilization

[00860003118351]

Moist Heat or Steam Sterilization

[00860003118351]

Moist Heat or Steam Sterilization

[00860003118351]

Moist Heat or Steam Sterilization

[00860003118351]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-09-30
• Device Publish Date: 2021-09-22

Devices Manufactured by Canary Medical USA LLC

• 00860003118399 - Canturio® Smart Extension 14mm (D) x 30mm (H): 2024-09-20 Canturio® Smart Extension 14mm (D) x 30mm (H) with Canary Health Implanted Reporting Processor (CHIRP®) system is a tibial ext
• 00850015699153 - Home Base Station (Bluetooth): 2024-09-16 The Canary Home Base Station (Bluetooth) subsystem is a unit with embedded firmware that facilitate communication with CTE and C
• 00850015699115 - CanarE Strap: 2023-05-25
• 00850015699122 - Canary Clinic Cart: 2023-05-25
• 00850015699139 - CanarE Charging Cradle: 2023-05-25
• 00860003118344 - CanarE – Clinic Wearable Device: 2023-05-25
• 00860003118368 - Canary Clinic Base Station: 2023-05-25
• 00860003118382 - Clinic Laptop: 2023-05-25