510(k) K241470 ยท QHE Shoulder Arthroplasty Implantation System
CORE Shoulder System
| Applicant | LinkBio Corp., Dover NJ, US |
| Decision | Substantially Equivalent, Feb 20, 2025 |
| Received | May 24, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K241470
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 10, 2026 | Linkbio Corp. LinkBio CORE Workstation, a component of the CORE Shoulder System. Product Code: 87-9136. Open, Classified |
QHE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.