FRAXION 3.5 Plate System (Various - See Catalog) +3 more— 510(k) K261830

Name: FDA 510(k) clearance K261830
Creator: U.S. Food and Drug Administration
Published: 2026-08-28

Substantially Equivalent

Ortler 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.

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: Code HRS
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2026-06-02
Decision date: 2026-08-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ankara, TR

Download summary PDF View on FDA.gov ↗

Recent devices under product code HRS

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K262537 — Versalock Sterile Plating System2026-08-19
K260277 — MIKRON TRAUMA BONE PLATE& SCREW SYSTEM2026-08-13
K261511 — Xpert Ankle2026-07-28
K261406 — Versalock Proximal Tibial Plating System2026-07-21
K262032 — TriMed Non-Spanning Wrist Fusion Plates (4 models)2026-07-16

Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.