Identity
- Trade Name
- canturio™te Provisional FDA UDI
- Generic Name
- Knee tibia prosthesis trial, reusable FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 43-5571-058-14 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860003118351 FDA UDI
- 510(k) Number
- DEN200064 FDA UDI
- FDA Product Code
- QPP FDA UDI
- GMDN Term
- Knee tibia prosthesis trial, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3600 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Knee tibia prosthesis trial, reusable
canturio™te Provisional by Canary Medical Usa Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Knee tibia prosthesis trial, reusable.
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- ACS® — implantcast GmbH · Class I
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- SIGMA — DEPUY ORTHOPAEDICS, INC. · Class I
- INSTRUMENT — Howmedica Osteonics Corp. · Class I
Cleared under the same submission
DEN200064 also covers:
- canturio™ te Modular Bracket, Impaction Sleeve — CANARY MEDICAL USA LLC
- canturio™te — CANARY MEDICAL USA LLC
- canturio™te Canary Tibial Ext 14x58mm X-Ray Template — CANARY MEDICAL USA LLC
- canturio™te Cemented Tibia Drill Bit — CANARY MEDICAL USA LLC
- canturio™te Impaction Sleeve — CANARY MEDICAL USA LLC
- canturio™te Modular Bracket Drill Bit — CANARY MEDICAL USA LLC
- canturio™te Modular Bracket Stem Provisional — CANARY MEDICAL USA LLC
- canturio™te Modular Bracket Tibial Cutting Guide, Left; 5 Deg. — CANARY MEDICAL USA LLC
- canturio™te Modular Bracket Tibial Cutting Guide, Right; 5 Deg. — CANARY MEDICAL USA LLC
- canturio™te Tibia Resection Cutting Guide, Left, 5 Deg. — CANARY MEDICAL USA LLC
- canturio™te Tibia Resection Cutting Guide, Right, 5 Deg. — CANARY MEDICAL USA LLC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Canary Medical Usa Llc
Sources (1)
- FDA UDI f0d2e6d1-ba27-443f-84e9-a69118556264 34 fields · synced Jun 8, 2026