canturio™te Tibia Resection Cutting Guide, Right, 5 Deg.

GUDID 00850015699054

The Canary Medical Tibia Resection Cutting Guide (left or right option) is used for tibia preparation when implanting a Persona® Primary Knee with a Canary Medical Tibial Extension (CTE) Implant.

Canary Medical USA LLC

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• Primary Device ID: 00850015699054
• NIH Device Record Key: e2ce21d6-27ac-4afa-9e2d-243e2c01a1b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: canturio™te Tibia Resection Cutting Guide, Right, 5 Deg.
• Version Model Number: 43-5399-052-05
• 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	00850015699054 [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

[00850015699054]

Moist Heat or Steam Sterilization

[00850015699054]

Moist Heat or Steam Sterilization

[00850015699054]

Moist Heat or Steam Sterilization

[00850015699054]

Moist Heat or Steam Sterilization

[00850015699054]

Moist Heat or Steam Sterilization

[00850015699054]

Moist Heat or Steam Sterilization

[00850015699054]

Moist Heat or Steam Sterilization

[00850015699054]

Moist Heat or Steam Sterilization

[00850015699054]

Moist Heat or Steam Sterilization

[00850015699054]

Moist Heat or Steam Sterilization

[00850015699054]

Moist Heat or Steam Sterilization

[00850015699054]

Moist Heat or Steam Sterilization

[00850015699054]

Moist Heat or Steam Sterilization

[00850015699054]

Moist Heat or Steam Sterilization

[00850015699054]

Moist Heat or Steam Sterilization

[00850015699054]

Moist Heat or Steam Sterilization

[00850015699054]

Moist Heat or Steam Sterilization

[00850015699054]

Moist Heat or Steam Sterilization

[00850015699054]

Moist Heat or Steam Sterilization

[00850015699054]

Moist Heat or Steam Sterilization

[00850015699054]

Moist Heat or Steam Sterilization

[00850015699054]

Moist Heat or Steam Sterilization

[00850015699054]

Moist Heat or Steam Sterilization

[00850015699054]

Moist Heat or Steam Sterilization

[00850015699054]

Moist Heat or Steam Sterilization

[00850015699054]

Moist Heat or Steam Sterilization

[00850015699054]

Moist Heat or Steam Sterilization

[00850015699054]

Moist Heat or Steam Sterilization

[00850015699054]

Moist Heat or Steam Sterilization

[00850015699054]

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

• 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
• 00850015699016 - OR Barcode Scanner: 2021-10-07 After the surgery is completed, the OR Barcode Scanner can be used to scan the barcodes on the labels of the CTE and other impla
• 00860003118337 - OR Laptop: 2021-10-07 Dedicated Laptop PC, part of the OR Base Station System