FDA Registration
Active
🇨🇦 Canada
Intellijoint Surgical Inc.
Reg #: 3010822102
·
FEI: 3010822102
·
Expires 2026
Products
4
Proprietary Names
7
Establishment Types
3
Classifications
4
Registration Details
- Registration Name
- Intellijoint Surgical Inc.
- Registration Number
- 3010822102
- FEI Number
- 3010822102
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 809 Wellington St. N, Unit 2
- City
- Kitchener Ontario
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K033621
Owner / Operator
- Firm Name
- Intellijoint Surgical Inc.
- Operator Number
- 10047431
- Address
- 809 Wellington St. N, Unit 2
- City
- Kitchener
- State
- Ontario
- Postal Code
- N2H 5L6
- Country
- CA
US Agent
- Business Name
- PHIAMA, Inc.
- Contact Name
- Roger White
- Address
- 236 McKinley Park Ln
- City
- Louisville
- State
- CO
- ZIP
- 80027
- Country
- US
- [email protected]
- Phone
- 720 8904260
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2016-12-08 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2019-05-23 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2022-10-24 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2019-10-07 |
Proprietary Names
Passive Spheres(TM)
Camera Drape
Intellijoint VIEW
Intellijoint HIP
Intellijoint Navigation System
Intellijoint KNEE
intellijoint HIP(R)
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device