# Ortler Global Tibbi Gerecler Anonim Sirketi

- Location (FDA's records): Ankara, TR
- FDA decisions: 2 (2026–2026): 2 510(k) clearances
- Product codes: HRS (1), NKB (1)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Artfx Medical: 2 (https://510kreport.com/company/artfx-medical)

## Recent decisions
- K262091: FRAXION Spinal Fixation System (Sep 17, 2026)
- K261830: 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) (Aug 28, 2026)

Source page: https://510kreport.com/company/ortler-global-tibbi-gerecler-anonim-sirketi