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FDA opens a comment docket on the device regulatory science gaps of the next decade FDA makes the Boston Scientific Imager II removal a Class I recall Labs push the RESULTS Act after CMS cuts 775 test codes by the full 15 percent Boston Scientific clears SpaceOAR Flex, a rectal spacer the physician can stop mid-injection Shockwave founder Daniel Hawkins takes the board chair at Solenic Medical NeuroSigma takes its ADHD nerve stimulator into psychiatry clinics through Firefly's EEG network Intuitive wins a CE mark for adult cardiac surgery with da Vinci 5 Forj Medical opens a Costa Rica plant with ISO Class 8 cleanrooms and 50 staff Marani Health clears the M•care system for fetal and maternal monitoring at home FDA opens a comment docket on the device regulatory science gaps of the next decade FDA makes the Boston Scientific Imager II removal a Class I recall Labs push the RESULTS Act after CMS cuts 775 test codes by the full 15 percent Boston Scientific clears SpaceOAR Flex, a rectal spacer the physician can stop mid-injection Shockwave founder Daniel Hawkins takes the board chair at Solenic Medical NeuroSigma takes its ADHD nerve stimulator into psychiatry clinics through Firefly's EEG network Intuitive wins a CE mark for adult cardiac surgery with da Vinci 5 Forj Medical opens a Costa Rica plant with ISO Class 8 cleanrooms and 50 staff Marani Health clears the M•care system for fetal and maternal monitoring at home

The Tracker / September 2026 / K262091

510(k) cleared

FRAXION Spinal Fixation System

Ortler Global Tibbi Gerecler Anonim Sirketi · Sep 17, 2026 · K262091

FDA cleared the FRAXION Spinal Fixation System from Ortler Global Tibbi Gerecler Anonim Sirketi on Sep 17, 2026 under K262091, a traditional 510(k). The device falls under product code NKB, Thoracolumbosacral Pedicle Screw System, regulated at 21 CFR 888.3070 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Jun 22, 2026. The decision came 87 days later, inside the 90 FDA-day goal for a 510(k).

Ortler Global Tibbi Gerecler Anonim Sirketi has one other decision in the tracker over the last 12 months: 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)).

Questions & Answers

What did FDA clear under K262091?

K262091 is the FDA 510(k) for FRAXION Spinal Fixation System, submitted by Ortler Global Tibbi Gerecler Anonim Sirketi. FDA's decision date was Sep 17, 2026, under product code NKB (Thoracolumbosacral Pedicle Screw System).

Who makes the FRAXION Spinal Fixation System?

Ortler Global Tibbi Gerecler Anonim Sirketi, based in Ankara, is the applicant of record for K262091.

How long did the K262091 review take?

FDA received the submission on Jun 22, 2026 and issued its decision on Sep 17, 2026, 87 days later.

← All decisions in September 2026

Sources