K261830
- 510(k) number
- K261830
- Device name
- FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog)
- Applicant
- Ortler Global Tibbi Gerecler Anonim Sirketi TR
- Product code
- HRS — Plate, Fixation, Bone
- Decision date
- 2026-08-28
- Date received
- 2026-06-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.6 MB · U.S. public domain
Also available from FDA: K261830.pdf
Official FDA record: K261830
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.