FDA 510(k)
FDA class 2
Substantially Equivalent
🇦🇺 Australia
Precision AI Surgical Planning System (PAI-SPS)
K Number: K233992
·
Decision Aug 5, 2024
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
25
Applicant Total
3
Review Days
231
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Precision AI Surgical Planning System (PAI-SPS)
- K Number
- K233992
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3660
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Precision AI Pty, Ltd.
- Date Received
- December 18, 2023
- Decision Date
- August 5, 2024
- Product Code
- QHE
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QHE | Shoulder Arthroplasty Implantation System | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QHE), ordered by most recent decision date.
Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner
FDA 510(k)
FDA Class 2
·Orthopedic
Signature ONE System
FDA 510(k)
FDA Class 2
·Orthopedic
Signature ONE System
FDA 510(k)
FDA Class 2
·Orthopedic
Precision AI Surgical Planning System (PAI-SPS)
FDA 510(k)
FDA Class 2
·Orthopedic
Archer PSI System
FDA 510(k)
FDA Class 2
·Orthopedic
CORE Shoulder System
FDA 510(k)
FDA Class 2
·Orthopedic