K241470
- 510(k) number
- K241470
- Device name
- CORE Shoulder System
- Applicant
- LinkBio Corp. NJ · US
- Product code
- QHE — Shoulder Arthroplasty Implantation System
- Decision date
- 2025-02-20
- Date received
- 2024-05-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K241470.pdf
Official FDA record: K241470
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.