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

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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