510(k) clearance
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)
- 510(k) number
- K261830
- Applicant
- Ortler Global Tibbi Gerecler Anonim Sirketi
- Decision date
- Aug 28, 2026
- Date received
- Jun 2, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- HRS
- Device type
- Plate, Fixation, Bone
- Device class
- Class II
- Regulation
- 21 CFR 888.3030
- Advisory committee
- Orthopedic
- Statement or summary
- Summary
- Third party
- N
- Location
- Ankara, TR