FDA Registration
Active
🇦🇺 Australia
PRECISION AI PTY LTD
Reg #: 3031914485
·
FEI: 3031914485
·
Expires 2026
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- PRECISION AI PTY LTD
- Registration Number
- 3031914485
- FEI Number
- 3031914485
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Suite 18, 36 Agnes Street, Fortitude Valley
- City
- Brisbane Queensland
- Country
- AU
Regulatory Submissions
- 510(k) Number
- K243955
Owner / Operator
- Firm Name
- Precision AI Pty Ltd
- Operator Number
- 10091281
- Address
- Suite 18, 36 Agnes Street, Fortitude Valley
- City
- Brisbane
- State
- Queensland
- Postal Code
- 4006
- Country
- AU
- Correspondent
- Daniel Ward
US Agent
- Business Name
- Encore Medical
- Contact Name
- Sherri Mellingen
- Address
- 9800 Metric Blvd
- City
- Austin
- State
- TX
- ZIP
- 78758
- Country
- US
- [email protected]
- Phone
- 512 8329500
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2025-09-11 |
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2025-09-11 |
| Shoulder Arthroplasty Implantation System | QHE | Class 2 | Orthopedic | No | 2025-09-11 |
Proprietary Names
Precision AI Surgical Planning System (PAI-SPS)
Establishment Types
Manufacture Medical Device