FRAXION 3.5 Plate System (Various - See Catalog) +3 more— 510(k) K261830
Substantially EquivalentOrtler Global Tibbi Gerecler Anonim Sirketi
FDA 510(k) clearance K261830 for FRAXION 3.5 Plate System (Various - See Catalog) +3 more, Substantially Equivalent on 2026-08-28. Applicant: Ortler Global Tibbi Gerecler Anonim Sirketi. Device class: 2.
Summary
Ortler Global Tibbi Gerecler's submission lists four FRAXION systems: the 3.5 Plate System, 4.5 Plate System, Mini Plate System, and Bone Screw System. The record gives the models for each only as "Various - See Catalog". The product code is HRS, bone fixation plates.
Class II, 21 CFR 888.3030. Orthopedic is both the classification panel and the review panel, and it came in as a Traditional 510(k).
The applicant filed from Ankara, Turkey. The substantially equivalent decision came 87 calendar days after receipt (June 2 to August 28, 2026).
Clearance details
- Device name as filed
- 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
- Product code
- Product code HRS
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ankara, TR
Recent devices under product code HRS
view allMore clearances from Ortler Global Tibbi Gerecler Anonim Sirketi
view allAdverse events under product code HRS
product code HRS- Death
- 27
- Injury
- 10,340
- Malfunction
- 3,328
- Total
- 13,695
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.