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canturio™te Modular Bracket Tibial Cutting Guide, Right +1 more model
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- canturio™te Modular Bracket Tibial Cutting Guide, Right; 5 Deg. FDA UDI
- Generic Name
- Device sterilization/disinfection container, reusable FDA UDI
- Device Name
- Tibial Cutting guide is placed within a tray, held in place by reusable Modular Brackets that contact the Instruments during sterilization and storage (while inside the Tray), but have no patient contact themselves. FDA UDI
- Model / Reference
- 43-5907-080-29 FDA UDI
- Description
- Tibial Cutting guide is placed within a tray, held in place by reusable Modular Brackets that contact the Instruments during sterilization and storage (while inside the Tray), but have no patient contact themselves. FDA UDI
Identifiers
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: Device sterilization/disinfection container, reusable
canturio™te Modular Bracket Tibial Cutting Guide, Right +1 more model by Canary Medical Usa Llc — Class II — FDA UDI — listed in FDA GUDID — 2 models
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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 Provisional — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Canary Medical Usa Llc
Sources (1)
- FDA UDI c7bee717-1ebb-43c7-b8f4-909e142a7f5e 34 fields · synced Jun 6, 2026