510(k) K251558 ยท QHE Shoulder Arthroplasty Implantation System
Precision AI Surgical Planning System (PAI-SPS)
| Applicant | Precision AI Pty, Ltd., Fortitude Valley, AU |
| Decision | Substantially Equivalent, Jan 12, 2026 |
| Received | May 21, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251558
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.