FDA 510(k)

OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System

N.º K: K252885 · 2026-01-22

Fecha de decisión2026-01-22

Código de productoPML

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Astura Medical. It received FDA 510(k) clearance on 2026-01-22 under 510(k) number K252885. The device is classified under product code PML. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System?

OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2026-01-22. The listed applicant is Astura Medical. The 510(k) number is K252885.

When did OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System receive FDA 510(k) clearance?

OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System received FDA 510(k) clearance on 2026-01-22, under 510(k) number K252885.

Who is the listed applicant for OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System?

The FDA 510(k) record lists Astura Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System?

The FDA product code for OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System is PML.

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Otros registros que enlistan a Astura Medical como solicitante

K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System K243259MASADA Modular Spinal Fixation System K240160EGPS Navigated Instruments K233359DOMINION Expandable Corpectomy System K231694MASADA Modular Spinal Fixation System K232211REUNION Sacroiliac Joint Fusion System

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Dispositivos relacionados (Código: PML)

K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone CementUlrich Medical USA K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart K222789VADER® Pedicle System, G21 CementIcotec AG K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.

Fuente oficial

Ver en la base de datos de la FDA →

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