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canturio™te Tibia Resection Cutting Guide, Left, 5 Deg.
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- canturio™te Tibia Resection Cutting Guide, Left, 5 Deg. FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 43-5399-051-05 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850015699023 FDA UDI
- 510(k) Number
- DEN200064 FDA UDI
- FDA Product Code
- QPP FDA UDI
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, 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: Orthopaedic prosthesis implantation positioning instrument, reusable
canturio™te Tibia Resection Cutting Guide, Left, 5 Deg. by Canary Medical Usa Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic prosthesis implantation positioning instrument, reusable.
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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 Provisional — 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 ba9d110e-a9f8-41d2-8ca3-d6c7551fb5ca 34 fields · synced Jun 6, 2026