FDA 510(k)

SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments

N.º K: K260571 · 2026-06-02

Fecha de decisión2026-06-02

Código de productoOLO

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Life Spine, Inc.. It received FDA 510(k) clearance on 2026-06-02 under 510(k) number K260571. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments?

SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments is a medical device that received FDA 510(k) clearance on 2026-06-02. The listed applicant is Life Spine, Inc.. The 510(k) number is K260571.

When did SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments receive FDA 510(k) clearance?

SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments received FDA 510(k) clearance on 2026-06-02, under 510(k) number K260571.

Who is the listed applicant for SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments?

The FDA 510(k) record lists Life Spine, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments?

The FDA product code for SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments is OLO.

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Otros registros que enlistan a Life Spine, Inc. como solicitante

K261430TruLift Expandable System K260837VersaLift Expandable System K254274Sistema de Implante ARx® SAI K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer System K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate System K250373ProLift Expandable Spacer System

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Dispositivos relacionados (Código: OLO)

K262506Remex Spine Surgery Navigation - Universal InstrumentsRemex Medical Corp.K261410Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))Suite 201, National Innovation Centre K261205SPINEART Navigation Instrument SystemSpineart SA K261024TMINI Miniature Robotic SystemTHINK Surgical, Inc.K262121Ion-L Navigated InstrumentsSurGenTec, LLC K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics

Fuente oficial

Ver en la base de datos de la FDA →

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