FDA 510(k)

FRAXION Spinal Fixation System

Número K: K262091 · 2026-09-17

RequerenteOrtler Global Tibbi Gerecler Anonim Sirketi

Data da decisão2026-09-17

Código do produtoNKB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

FRAXION Spinal Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Ortler Global Tibbi Gerecler Anonim Sirketi. It received FDA 510(k) clearance on 2026-09-17 under 510(k) number K262091. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the FRAXION Spinal Fixation System?

FRAXION Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2026-09-17. The listed applicant is Ortler Global Tibbi Gerecler Anonim Sirketi. The 510(k) number is K262091.

When did FRAXION Spinal Fixation System receive FDA 510(k) clearance?

FRAXION Spinal Fixation System received FDA 510(k) clearance on 2026-09-17, under 510(k) number K262091.

Who is the listed applicant for FRAXION Spinal Fixation System?

The FDA 510(k) record lists Ortler Global Tibbi Gerecler Anonim Sirketi as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FRAXION Spinal Fixation System?

The FDA product code for FRAXION Spinal Fixation System is NKB.

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Outros registros que listam Ortler Global Tibbi Gerecler Anonim Sirketi como candidato(a)

K261830FRAXION 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)

Dispositivos Relacionados (Código: NKB)

K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd.K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface TechnologyXenix Medical K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)MANTIZ Co., Ltd.K253943Tiger 2 SystemZavation Medical Products, LLC

Fonte oficial

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