K251558
- 510(k) number
- K251558
- Device name
- Precision AI Surgical Planning System (PAI-SPS)
- Applicant
- Precision AI Pty, Ltd. AU
- Product code
- QHE — Shoulder Arthroplasty Implantation System
- Decision date
- 2026-01-12
- Date received
- 2025-05-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K251558.pdf
Official FDA record: K251558
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.