510(k) Report

FDA applicant

Ortler Global Tibbi Gerecler Anonim Sirketi

Ankara, TR2 decisions2026–20260 recalls

FDA records 2 decisions for Ortler Global Tibbi Gerecler Anonim Sirketi (Ankara, TR) in 2026: 2 510(k) clearances. Most are in product codes HRS (Plate, Fixation, Bone) and NKB (Thoracolumbosacral Pedicle Screw System). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Ortler Global Tibbi Gerecler Anonim Sirketi’s devices, and how often a recall has named them.

FDA decisions per year

2in 2026

2026 (partial year): 2
2026high 2 (2026)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2026.

FIG. 1 — Ortler Global Tibbi Gerecler Anonim Sirketi by year, 2026–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • HRSPlate, Fixation, Bone1decision
  • NKBThoracolumbosacral Pedicle Screw System1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K262091FRAXION Spinal Fixation SystemOrtler Global Tibbi Gerecler Anonim Sirketi · 2026
  • K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION…Ortler Global Tibbi Gerecler Anonim Sirketi · 2026

All 2 as Ortler Global Tibbi Gerecler Anonim Sirketi →