K240613
- 510(k) number
- K240613
- Device name
- APTUS Elbow Dorsal Olecranon Plates
- Applicant
- Medartis AG CH
- Product code
- HRS — Plate, Fixation, Bone
- Decision date
- 2024-06-20
- Date received
- 2024-03-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.3 MB · U.S. public domain
Also available from FDA: K240613.pdf
Official FDA record: K240613
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.