Medical Device Manufacturer · TR , Ankara

Ortler Global Tibbi Gerecler Anonim Sirketi - FDA 510(k) Cleared Devi...

2 submissions · 2 cleared · Since 2026

Recent clearances: FRAXION Spinal Fixation System, FRAXION 3.5 Plate System (Various - See Catalog)

View 2 510(k) Devices ↓
2
Total
2
Cleared
0
Denied

FDA 510(k) Regulatory Record - Ortler Global Tibbi Gerecler Anonim Sirketi Orthopedic ✕

2 devices
1-2 of 2
Cleared Sep 17, 2026
FRAXION Spinal Fixation System
K262091 · NKB
Orthopedic · 87d
Cleared Aug 28, 2026
FRAXION 3.5 Plate System (Various - See Catalog)
K261830 · HRS
Orthopedic · 87d
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