FDA Registration
Active
🇺🇸 United States
canturio - te Tibia Resection Cutting Guide, Left, 5 Deg.
Reg #: 3015802419
·
FEI: 3015802419
·
Expires 2025
Products
1
Proprietary Names
12
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- CANARY MEDICAL USA LLC
- Registration Number
- 3015802419
- FEI Number
- 3015802419
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2710 Loker Ave. West, Suite 350
- City
- Carlsbad
- State
- CA
- ZIP
- 92010
- Country
- US
Regulatory Submissions
- 510(k) Number
- DEN200064
Owner / Operator
- Firm Name
- Canary Medical, Inc.
- Operator Number
- 10082445
- Address
- 2090 - 1055 West Georgia St.
- City
- Vancouver
- State
- British Columbia
- Postal Code
- V6E 3R5
- Country
- CA
- Correspondent
- Nora York
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Implantable Post-Surgical Kinematic Measurement Knee Device | QPP | Class 2 | Orthopedic | No | 2021-08-30 |
Proprietary Names
canturio - te Tibia Resection Cutting Guide, Left, 5 Deg.
canturio - te Modular Bracket Tibial Cutting Guide, Left; 5 Deg.
canturio - te Canary Tibial Ext 14x58mm X-Ray Template
canturio - te Provisional
canturio - te Modular Bracket Tibial Cutting Guide, Right; 5 Deg.
canturio - te Modular Bracket Stem Provisional
canturio - te Modular Bracket, Impaction Sleeve
canturio - te Cemented Tibia Drill Bit
canturio - te Impaction Sleeve
canturio te (CTE) with CHIRP System
canturio - te Modular Bracket Drill Bit
canturio - te Tibia Resection Cutting Guide, Right, 5 Deg.
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198