K253916
- 510(k) number
- K253916
- Device name
- APTUS Shoulder Proximal Humerus System, PentaLock 3.5
- Applicant
- Medartis AG CH
- Product code
- HRS — Plate, Fixation, Bone
- Decision date
- 2026-03-16
- Date received
- 2025-12-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.5 MB · U.S. public domain
Also available from FDA: K253916.pdf
Official FDA record: K253916
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.