510(k) K261830 ยท HRS Plate, Fixation, Bone
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, Ankara, TR |
| Decision | Substantially Equivalent, Aug 28, 2026 |
| Received | Jun 2, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261830
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.