FDA 510(k) clearance · back to tracker

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)

Ortler Global Tibbi Gerecler Anonim Sirketi cleared K261830 on 2026-08-28, decision: substantially equivalent

K-number

K261830

Sponsor

Ortler Global Tibbi Gerecler Anonim Sirketi

Device

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)

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-08-28

Product code

HRS

Advisory committee

Orthopedic

Medical specialty

Orthopedic

Regulation number

888.3030

Official FDA record

Open K261830on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Compass pulls the predicate's intended use, technological characteristics, and performance data, maps them against your device, and produces a draft SE table aligned to FDA's 510(k) program guidance.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.