K242988
- 510(k) number
- K242988
- Device name
- Genostis Osteosynthesis System
- Applicant
- Genostis AF CH
- Product code
- HRS — Plate, Fixation, Bone
- Decision date
- 2025-06-27
- Date received
- 2024-09-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.7 MB · U.S. public domain
Also available from FDA: K242988.pdf
Official FDA record: K242988
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.