FDA Registration
Active
🇦🇺 Australia
ARVIS® Shoulder
Reg #: 3013552417
·
FEI: 3013552417
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
2
Classifications
3
Registration Details
- Registration Name
- KICO KNEE INNOVATION COMPANY
- Registration Number
- 3013552417
- FEI Number
- 3013552417
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Unit 1, 25 Frenchs Forest Rd E
- City
- Frenchs Forest New South Wales
- Country
- AU
Regulatory Submissions
- 510(k) Number
- K240062
Owner / Operator
- Firm Name
- Kico Knee Innovation Company
- Operator Number
- 10054916
- Address
- Unit 1, 25 Frenchs Forest Rd E
- City
- Frenchs Forest
- State
- New South Wales
- Postal Code
- 2086
- Country
- AU
- Correspondent
- Danyon Munro
US Agent
- Business Name
- Encore Medical, L.P.
- Contact Name
- Sherri Mellingen
- Address
- 9800 Metric BLVD
- City
- Austin
- State
- TX
- ZIP
- 78758
- Country
- US
- [email protected]
- Phone
- 952 9136383
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | Class 2 | Radiology | No | 2024-12-12 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2024-12-12 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2024-12-12 |
Proprietary Names
ARVIS® Shoulder
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198